Careers

Consider a career at Norwich Pharma Services

Norwich believes that in order to produce the highest quality pharmaceutical products, our diverse staff should possess exceptional skills, including leadership, flexibility, commitment and technical expertise. Talent is key—and so is teamwork.

Our employees work in team environments where customer focus, passion and innovation are a way of life. Teams are responsible for achieving production timelines, meeting performance goals and maintaining the consistently high standards of quality for which we are known. As a Norwich employee, you’ll work as an integral part of a business team.

We welcome job candidates who possess strong skills, a commitment to excellence and a desire to contribute to our vital, growing organization.

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QA Doc Control - Sys Administrator Commercial Records

SUMMARY OF POSITION

 

The QA Document Control – System Administrator Commercial Records is responsible for commercial records, and associated SAP material master data.  Maintains designated quality systems, including Production Documentation and Document Control systems to ensure delivery against Quality Assurance (QA) department goals and objectives.

 

ORGANIZATION STRUCTURE

 

The QA Document Control – System Administrator Commercial Records reports to QA Manager Document Control.

 

RESPONSIBILITIES

 

Primary responsibilities of this role include the following:

 

1.   Commercial Master Batch Records

 

  1. Create and revise all commercial master batch records, checking all documents for general accuracy, alignment with current standards, and overall GMP compliance.
  2. Create, change and maintain SAP data for master batch records.
  3. Coordinate commercial master batch record approvals internally and with customers.
  4. Maintain all approved commercial master batch records.

 

2.   Commercial Cleaning Records

 

  1. Create and revise all commercial cleaning records, checking all documents for general accuracy, alignment with current standards, and overall GMP compliance.
  2. Coordinate commercial cleaning record approvals internally.
  3. Maintain all approved commercial cleaning records.

 

3.  Provide support for other Document Control systems, as required.

 

QUALIFICATIONS

 

  1. AAS degree in Chemistry, Life Science, Engineering, or combination of training, education, and experience that is equivalent.    
  2. A minimum of 5 years’ Pharmaceutical industry experience, including experience in Quality Standards, Quality Control, or Document Control. 
  3. Strong written and oral communication skills and the ability to work well with diverse groups including customers, management and technicians.  This includes the ability to work in a team environment.  

 

GMP DECISION-MAKING AUTHORITY

 

Has authority to approve GMP documentation as designated by Quality Leadership, as needed.

 

  EOE/M/F/Vet/Disability

 


Instructional Designer

SUMMARY OF POSITION

 

The Instructional Designer (ID) works with subject matter experts (SME’s) to analyze and document job-specific performance requirements.  The ID then creates and maintains support materials and training solutions, which are used to effectively transfer the identified knowledge and skills to others.  While some projects will likely include HR/Corporate training, the primary focus of this position is in support of technical, equipment-based training.

 

ORGANIZATION STRUCTURE

 

This position reports to the Training Manager.  The ID will primarily work with production technicians, the Training Manager and two Training Coordinators.

 

RESPONSIBILITIES

 

  1. Work with subject matter experts (SME’s) to analyze, document and maintain training and work qualification performance standards.
  2. Help promote and ensure the continuous improvement of systemic training processes and support solutions through positive, team-oriented actions.
  3. Provide Training design and evaluation services as priorities and time permit.
  4. Create and administer training courses, curricula and assignments in our Learning Management System.

 

QUALIFICATIONS

  • Master’s Degree in Instructional Design /3 years of Technical Training design and delivery experience or equivalent combination of technical hands-on skills and education.
  • Technical hands-on experience with computer controlled machines
  • ID experience in a manufacturing environment
  • Strong communication skills/EQ:  Able to work well with a variety of personalities at various levels in the organization.  Able to have challenging conversations without taking disagreements personally.
  • Strong and practical instructional design skills:  Customer-focused.   Able to simplify complex concepts to facilitate learning and support job performance.  High quality standards, but able to accept less-than-perfect solutions that engage and develop others.
  • Leadership skills:  Models leadership.  Understands the role of training in a business.  Team player.  Very comfortable with change.  Able to redirect conversations to move projects toward effective and efficient solutions.  Able to lead others in a manner that promotes mutual respect and mutual ownership of accomplishments.  Able to multi-task, lead and prioritize projects across multiple departments.
  • Self-starter who takes ownership for accomplishing assigned tasks
  • Experienced user: MS Office applications: Word, PowerPoint, Excel

 

EOE/M/F/Vet/Disability

 


Stability Coordinator

SUMMARY OF POSITION

 

The Stability Coordinator is responsible for all aspects of the stability sample program. The Stability Coordinator initiates and manages stability studies, including protocol development and maintenance, sample handling, and data reporting.

 

ORGANIZATION STRUCTURE

 

The Stability Coordinator reports to the QC Manager.

 

RESPONSIBILITIES

 

Primary responsibilities of this role include the following:

 

  1. Regulatory Stability Protocol Management
    1. Create and maintain Regulatory Stability Protocols based on the expected customer registered requirements and in compliance with all currentICHregulatory guidances.
    2. Work directly with project team and customers to define registered stability commitments for study design, testing requirements, and stability specifications.
    3. Calculate sample quantities required for testing by reviewing the applicable test methods, and calculate number of samples required per study based on pack types and storage conditions.
    4. Review specification changes for product,API, and packaging components to assess impact to Regulatory Stability Protocols and revise protocols as needed using appropriate change management systems.
  2. Study Protocol Management
    1. Create, review, and/or approve batch specific stability study protocols and summary report tables.
    2. Submit sample request form to be included with the production record.
    3. Assign stability study identification numbers and stability sample quantities/storage condition for batch records that include procedures for stability sampling.
    4. Ensure samples are labeled properly and distribute to appropriate stability chamber(s) for storage.
    5. Work directly with customers to revise stability study protocols as needed throughout study lifetime.
  3. Study Scheduling and Implementation
    1. Maintain schedule of stability pulls, testing deadlines, and reporting deadlines.
    2. Remove samples from stability chambers and coordinate sample delivery to the appropriate NPI or contract testing laboratory.
    3. Deliver stability data to customers.
    4. Work directly with customer service, project management, and finance to ensure proper charges made for stability testing.
    5. Dispose of samples when study is completed or discontinued.
    6. Notify and coordinate with Metrologists in the event of an issue with stability chamber performance.
    7. Participate in stability improvement projects.
  4. Compliance Activities
    1. Participate in audits as needed.
    2. Complete corrective and preventive actions assigned by investigations or audit observations.
    3. Prepare stability data tables and summary reports as needed for customers to use in their NDA Annual Reports or ongoing regulatory and/or stability data review processes.
    4. Review stability summary data tables for compliance and trends. Ensure any stability issues or potential issues are appropriately communicated to laboratory management.
    5. Participate in investigations as needed
  5. Additional duties as required

 

QUALIFICATIONS

 

  1. BS in chemistry or related field, plus 3-5 years of pharmaceutical QC laboratory experience, or equivalent combination of education and experience.
  2. Excellent oral and written communication skills.
  3. Proficient in computer use (Word, Excel, PowerPoint, internet) with ability to learn new computer applications.
  4. Ability to comprehend and follow standard operating procedures and test methods.
  5. Strong attention to detail and ability to multitask.
  6. Operates with a sense of urgency in a fast-paced environment.
  7. Strong organization, communication, and interpersonal skills.

 

GMP DECISION-MAKING AUTHORITY

 

  1. Authors regulatory documents and reports.
  2. Authors and revises stability protocols.
  3. Authors investigations as needed.
  4. Maintains and implements stability sample pull schedule.
  5. Reviews and reports stability data.
  6. Participates in audits as required.

 

EOE/M/F/Vet/Disability

 


Research Associate

SUMMARY OF POSITION

 

The Research Associate performs activities supporting the laboratory function in executing daily operations of the Method Development & Analytical Services (MDAS) Laboratories.

 

ORGANIZATION STRUCTURE

 

The Research Associate directly reports to a Senior Research Associate, Group Leader, Manager or Director.

 

RESPONSIBILITIES

 

  1. Support Laboratory Functions:
    1. Laboratory housekeeping duties
    2. Maintain laboratory equipment
    3. Maintain adequate supplies
    4. Perform laboratory procedures in accordance with approved procedures/documents
    5. Operation of equipment in accordance with approved procedures/documents
  2. Activities supporting the development and validation of manufacturing processes
    1. Assist in identifying key process parameters and their impact on product quality
    2. Assist in the development of solutions and action plans to address quality and production improvements
    3. Assist in development and execution of equipment installation and operational qualifications
    4. Assist in development and execution of process validations
    5. Technical resource for the Operations Department
    6. Maintain adequate supplies
    7. Assist in initial room designs, equipment specifications
  3. Administrative duties
    1. Assist in preparing documents
    2. Maintain laboratory records/files
    3. Use statistical methods to determine in-control/out of control processes
  4. Training
    1. Assist in the development of training materials
    2. Train others
  5. Leadership
    1. Ensure correct, up-to -date technical information is readily available and being used by the operating team
    2. Lead and execute design of experiments

 

QUALIFICATIONS

 

  1. BS degree in related field
  2. Strong oral and written communications skills
  3. Proficient in computer use (Word, Excel, internet) with ability to learn new computer applications
  4. Ability to follow standard operating procedures to perform work function
  5. Strong clerical aptitude, sound judgment and operates with a sense of urgency in a fast paced environment
  6. Strong interpersonal skills

 

GMP DECISION-MAKING AUTHORITY

 

The Research Associate has authority to perform work as assigned supporting the laboratory function or supporting development and validation of manufacturing processes. This includes following approved procedure and guidance received from supervisors.

 

EOE/M/F/Vet/Disability


Micriobiologist I

SUMMARY OF POSITION

 

The Quality Control Microbiologist I:

  • Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications.
  • Performs routine testing in conformance with approved procedures, accurately and concisely documents data, and reports results.
  • Demonstrates a basic knowledge of SOP’s and GMP regulations as related to the pharmaceutical quality control laboratory.

 

ORGANIZATION STRUCTURE

 

The Quality Control Microbiologist I reports into the Manager Quality Control or Team Leader Quality Control.

 

RESPONSIBILITIES

 

Primary responsibilities of this role include the following:

 

  • Safety
    • Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. – OSHA) requirements
    • Participate in weekly/monthly safety training, identify potential safety hazards and cooperate with investigations of safety related incidents
    • Compliance
      • Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendia standards, FDA expectations and internal procedures
      • Assist with laboratory investigations to ensure they are conducted in a timely manner and are completed within established target completion dates
      • Maintain required level of training needed to perform a GMP task
      • Productivity
        • Perform routine sample analysis requiring general laboratory skills such as weighing, pipetting, and basic operation of laboratory instrumentation
        • Comprehend and follow approved test methods accurately in the performance of sample analysis to ensure adherence to “Right-the First Time” philosophy
        • Perform analysis with a practical understanding of the test procedure and instrument operation
        • Use available software to control instrumentation, collect data, process and calculate results, and report results
        • Perform testing to evaluate bioburden of raw materials and finished products
        • Work under direction provided by supervisor
        • Calculate results and assess conformance with specifications
        • Notify manager immediately of nonconforming data or unexpected occurrences
        • Organize work schedule to complete assigned tasks efficiently and on schedule
        • Maintain accurate record of analysis and perform documentation to company standards
        • Prepare test solutions, reagents, media, and samples used in analysis
        • Other duties as assigned

 

QUALIFICATIONS

 

  • BS in Microbiology or related discipline
  • 0-3 years experience in a pharmaceutical QC laboratory environment
  • Understanding of cGXP requirements preferred
  • Organization, communication and interpersonal skills

 

GMP DECISION-MAKING AUTHORITY

 

Responsible for decisions related to:

  • When laboratory management must be notified to determine whether an investigation is warranted
  • Maintain required level of training needed to perform a GMP task
  • Suitability of analytical equipment/instruments for use

 

EOE/M/F/Vet/Disability

 

 


Quality Control Center Lab Technician

SUMMARY OF POSITION

 

The Quality Control (QC) Lab Technician is an entry-level position in the QC Laboratory. The QC Lab Technician is responsible for performing routine sample analyses in a cGMP environment, provide support to ongoing laboratory activities, and participate in special projects.

 

ORGANIZATION STRUCTURE

 

The QC Lab Technician reports to the QC Manager or QC Associate Director.

 

RESPONSIBILITIES

 

Primary responsibilities of this role include the following:

 

  1. Performs analysis on routine laboratory samples in the raw materials or finished product group.
    1. Prepares test solutions, reagents, and standards
  2. Maintains accurate records using laboratory notebooks and computer systems.
  3. Additional duties as assigned.

 

QUALIFICATIONS

 

  1. High school diploma plus 3 years laboratory experience, or Associate’s Degree in a technical discipline.
  2. Proficient in computer use (Outlook, Word, Excel, PowerPoint) with ability to learn new computer applications.
  3. Strong oral and written communication skills.
  4. Ability to comprehend and follow Standard Operating Procedures and test methods.

 

GMP DECISION-MAKING AUTHORITY

 

None.

 

EOE/M/F/Vet/Disability


Chemist I

SUMMARY OF POSITION

 

The Quality Control Chemist I / Microbiologist I:

  • Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications.
  • Performs routine testing in conformance with approved procedures, accurately and concisely documents data, and reports results.
  • Demonstrates a basic knowledge of SOP’s and GMP regulations as related to the pharmaceutical quality control laboratory.

 

ORGANIZATION STRUCTURE

 

The Quality Control Chemist I / Microbiologist I reports into the Manager Quality Control or Team Leader Quality Control.

 

RESPONSIBILITIES

 

Primary responsibilities of this role include the following:

 

  • Safety
    • Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. – OSHA) requirements
    • Participate in weekly/monthly safety training, identify potential safety hazards and cooperate with investigations of safety related incidents
    • Compliance
      • Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendia standards, FDA expectations and internal procedures
      • Assist with laboratory investigations to ensure they are conducted in a timely manner and are completed within established target completion dates
      • Maintain required level of training needed to perform a GMP task
      • Productivity
        • Perform routine sample analysis requiring general laboratory skills such as weighing, pipetting, titration, and basic operation of laboratory instrumentation
        • Comprehend and follow approved test methods accurately in the performance of sample analysis to ensure adherence to “Right-the First Time” philosophy
        • Perform analysis with a practical understanding of the test procedure and instrument operation
        • Use available software to control instrumentation, collect data, process and calculate results, and report results
        • Perform testing to evaluate physical characteristics of raw materials and finished products
        • Work under direction provided by supervisor
        • Calculate results and assess conformance with specifications
        • Notify manager immediately of nonconforming data or unexpected occurrences
        • Organize work schedule to complete assigned tasks efficiently and on schedule
        • Maintain accurate record of analysis and perform documentation to company standards
        • Prepare test solutions, reagents, and samples used in analysis
        • Other duties as assigned

 

QUALIFICATIONS

 

  • BS in Chemistry, Biochemistry, Microbiology or Biology or related discipline
  • 0-3 years experience in a pharmaceutical QC laboratory environment
  • Understanding of cGXP requirements preferred
  • Organization, communication and interpersonal skills

 

GMP DECISION-MAKING AUTHORITY

 

Responsible for decisions related to:

  • When laboratory management must be notified to determine whether an investigation is warranted
  • Maintain required level of training needed to perform a GMP task
  • Suitability of analytical equipment/instruments for use

 

EOE/M/F/Vet/Disability


Department Manager Health & Safety

SUMMARY OF POSITION

 

This position leads and oversees the Health & Safety Department and has the ultimate responsibility to ensure the overall organization has an effective EHS management system that minimizes risk to personnel, property, environment, and the business, while at a minimum abiding to all applicable regulations.

 

ORGANIZATION STRUCTURE

 

The Department Manager Health & Safety reports directly to the Vice President Operations.  The Coordinator Health & Safety, Environmental Leader, and contracted Environmental group report to the Department Manager, Heath & Safety.

 

RESPONSIBILITIES

 

Primary responsibilities of this role include the following:

 

  1. Department Leadership
    1. Ensure department staff have strategic direction, required training as well as appropriate coaching and professional growth
    2. Ensure environmental contractor compliance with contract
    3. Responsible for EHS expenses and capital budget
    4. Ensure effective department service to all levels of the organization
  2. Plant Safety
    1. Perform safety assessment for new materials
    2. Ensures Plant readiness and response plan for all types of emergencies
    3. Ensures an effective training program is executed and maintained
    4. Oversee incident investigation program
    5. Develop, maintain and communicate organization’s safety metrics
    6. Lead and continuously improve all environmental and health & safety programs
  3. Worker’s Compensation Case Management
    1. Provides support with FMLA and disability cases
    2. Manage OSHA log
  4. Oversee Contract Environmental and DOT
    1. Ensure all environmental permits are maintained and current
    2. Responsible for on-time inspections
    3. Oversee facility water treatment systems and assure all activities are within permit limits
    4. Oversee waste shipments and ensure EPA, NYS and DOT regulations are met

 

 

QUALIFICATIONS

 

Education:  Bachelor of Science or Engineering

Experience:  5-10 years of experience in H&S Management

Leadership:  Minimum of 5 years with direct reports

 

GMP DECISION-MAKING AUTHORITY

 

  1. Review and approve documents as required
  2. Address unsafe acts and conditions as necessary, including the authorization to shut down operations
  3. Determination of appropriate authorization levels for department

 

EOE/M/F/Vet/Disability