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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Planner

SUMMARY OF POSITION

 

The Planner is responsible for obtaining forecasted demand and translating it into a material procurement and production plan that aligns with the master production schedule to deliver product on time per delivery requirements.

 

ORGANIZATION STRUCTURE

 

The Planner reports directly to the Director of Supply Chain.

 

RESPONSIBILITIES

 

Primary responsibilities of this role include the following:

 

  1. Materials Resource Planning (SAP Requirements)
    1. Manage and plan inventory requirements based on inventory MOH objectives, service levels and the demand forecast.  To include: maintain status and oversee management of product life cycles and associated material needs.
    2. Maintaining demand forecast and manage the Materials Resource Planning (MRP) process from the receipt of forecast, purchase of materials, to scheduling production, product testing and release, and finally to shipment of product for all assigned product accounts.

d.   Maintain supplier master data.

e.   Execute Open Order Report and follow-up with purchasing as needed to ensure on time deliveries.

 

  1. Business Execution
    1. Lead and manage production planning.
    2. Coordinate with Operations, Quality Assurance, Quality Control, and Supply Chain to ensure deliveries for all customers are satisfied. 
    3. Manage changes to the forecast, production plans, and/or delivery dates as needed on a routine basis.
    4. Ensure continuous, timely and appropriate communication to management and customers, both internal and external, on project issues, status and schedules.
    5. Supports Department and Site KPI’s
    6. Coordinates and communicates appropriate planning adjustment to cross functional peers and associates to meet and or exceed both internal and external customer business objectives
    7. Responsible for providing clear and concise direction and communication of scheduling dates, record review, lab testing, product release and final shipment coordination for all accounts assigned.
    8. Issue all production batch records to Operations, the Pharmacy and the Label Office daily to ensure production schedule is maintained and supporting reduced site cycle time goals and objectives.
    9. Conduct routine material checks, material retest analysis, and raw material delivery confirmation to ensure production plans stay on track.  Interventions are initiated and contingency plans put in place as needed to ensure deliveries are maintained for all customers.
    10. Manages procurement of inventory to minimize carrying cost through effective safety stock levels.
    11. Material Inventory tracking and reporting.

 

 

 

QUALIFICATIONS

 

  1. BS/BA degree in technical, business degree, or supply chain management or equivalent experience
  2. Ability to work in a team environment
  3. Attention to detail in a
  4. Strong interpersonal skills
  5. Strong problem solving skills
  6. Demonstrates knowledge of the manufacturing, packaging, maintenance, and PD&TS departments
  7. Experience with major ERP/MRP system (SAP, JD Edwards, etc.) required
  8. 5+ years’ experience in a Supply Chain role preferred
  9. APICS CSCP or CPIM certification preferred

 

GMP DECISION-MAKING AUTHORITY

 

  1. Follow all cGMP practices

 

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

 


Master Production Scheduler

SUMMARY OF POSITION

 

The Master Production Scheduler is responsible for establishing, distribution, and management of the weekly and monthly production schedules for both the making and packaging operations, long-range manufacturing load and critical product manufacturing processes for the site.  All site priority decisions in regards to production and/or plant maintenance are reviewed and scheduled via the production scheduler. 

 

ORGANIZATION STRUCTURE

 

The Master Production Scheduler reports directly to Director Supply Chain

 

RESPONSIBILITIES

 

Primary responsibilities of this role include the following:

 

  1. Scheduling
    1. Establish and manage daily, weekly, and monthly production scheduling process for the site and adjust schedules accordingly to deliver site goals and objectives.
    2. Works daily with Production Supervisors and Managers for optimal efficiency to meet the needs of internal and external customers.
    3. Ensure appropriate and timely communication to operations and management occurs when schedule adjustments and delays happen to align on priorities
    4. Provide “what if” capacity and schedule analysis as needed for changing demand requirements, staffing constraints, and new customer project awards to support efficient and timely delivery of all business needs.
    5. Supply manufacturing with rough cut capacity requirement planning.
    6. Organize and facilitate weekly scheduling meeting with Operations, PD&TS, FM, Quality Standards, Supply Chain, etc. to drive improved performance in schedule readiness and schedule adherence metrics for the site
    7. Provide leadership and recommend scheduling adjustments to management supporting changing business needs or customer requests
  2. Communication
    1. Coordinate with operations, PD&TS, FM, andCustomer Serviceto ensure deliveries for all customers are satisfied. 
    2. Manage and share changes to the forecast, production plans, and/or SOW changes requested by the customer on a routine basis
    3. Work with Material Planner,Customer Service, FM, and PD&TS team members to deliver the necessary customer requirements daily
  3. Documentation
    1. Manage and coordinate the SOP process for the planning department of Supply Chain 
    2. Ensure all corresponding SOP’s are updated, read, and signatures are turned back in to Quality Assurance in a timely and compliant manner
  4. Back-up facilitator for weekly SIOP meeting with middle and Executive management as needed

 

QUALIFICATIONS

 

  1. Demonstrated knowledge of the manufacturing, packaging, maintenance, and PD&TS departments.
  2. Advanced training and/or experience with the site production scheduling process, Pharmacy and Label Office operations, Supply Chain principles, and site wide SOP’s
  3. Excellent verbal and written communication skills, possession of advanced interpersonal and organizational skills.
  4. Exceptional personal computing skills including Excel, Word and SAP.
  5. Self directed, self-disciplined and highly organized.

 

GMP DECISION-MAKING AUTHORITY

 

  1. Responsible for providing clear and concise direction and communication of department priorities to include production schedules, cleaning and sampling, staffing changes, etc. to support site goals and objectives
  2. Coordinates and communicates all weekly overtime requirements to operations via the scheduling meeting to meet and or exceed customer requirements

 

EOE/M/F/Vet/Disability

 


Quality Systems Administrator - Change Management Labeling

SUMMARY OF POSITION

 

This position administers the Change Management Program and all associated system requirements, administers the SCL Labeling / Inserts/Outsert review program and supports Regulatory Inspections, internal and customer audits as required.  On request, provide support for other Quality Systems (QS) personnel.

 

ORGANIZATION STRUCTURE

 

The System Administrator - Change Management / Labeling reports to the Manager Quality Systems.

 

RESPONSIBILITIES

 

  1. Administer the Change Management Program:
    1. Change management administration for all systems requiring change control support (validation, production records, cleaning records, and analytical methods, etc.) 
    2. Maintain change management electronic records
    3. Review, assess, and approve change controls as required by SOP 
    4. Provide audit responses for audit observations 
    5. Provide training to company personnel on change management
  2. Design and implement change management process improvements where opportunities are identified
  3. Track metrics on change management. 
  4. Provide supporting data for Annual Product Review’s
  5. Provides support for other Quality Systems as required, i.e. SAP activities, Review & approval of Labeling, Inserts/Outserts
  6. Provide support for other QA personnel as necessary.

QUALIFICATIONS

 

  1. Associates degree in technical field or equivalent experience. 
  2. A minimum of 5+ years prior experience in a pharmaceutical manufacturing facility involving change control, quality systems, or quality assurance for manufacturing, packaging, quality control, and validation.
  3. 3 Years of QUMAS/Process Compliance experience or equivalent Electronic Document Management System (EDMS)
  4. Has knowledge of quality systems, predicate rule, FDA/ICHguidance documents, commonly used concepts, practices and procedures within a particular field.
  5. Ability to develop, implement, and manage a Change Management system. 
  6. Strong interpersonal skills and the ability to work well with diverse groups including customers, management and production technicians. This includes the ability to work in a team environment. 
  7. Strong organizational skills with the ability to lead team meetings and to manage multiple systems at one time. 
  8. Strong technical writing, computer and clerical skills. 
  9. Ability to work independently with little or no supervision and plan and accomplish goals.

 

GMP DECISION-MAKING AUTHORITY

 

Reviews and approves change controls and change management related records.  Maintains the Change Management Standard Operating Procedure.  These activities ensure quality levels are maintained and allow for the release of acceptable products.

 

EOE/M/F/Vet/Disability


Validation Manager

SUMMARY OF POSITION

 

The Manager Validation manages day to day activities of the validation group.  This position conducts validation assessments of equipment, facilities and process systems, makes recommendations for changes and/or improvements and approves appropriate change control documentation.

 

ORGANIZATION STRUCTURE

 

The Manager Validation reports directly to the Director Operations & Pharmaceutical Technology with (4) reporting Validation Engineers. 

 

RESPONSIBILITIES

 

Primary responsibilities of this role include the following:

 

  1. Leadership
    1. Ensure proper validation support
    2. Define areas of improvement
    3. Deliver strategic improvements to current systems
    4. Provide insight for capital expenditures to maintain quality/validation systems if needed
  2. Manage Primary Validation Initiatives
    1. Manage Equipment and Instrumentation Qualification Risk Assessment Program
    2. Manage Facility and Utility Qualification Program
    3. Manage Manufacturing Process Validation Program
    4. Manage Packaging Process Validation Program
    5. Manage Computer Validation Program
    6. Manage Cleaning Validation Program
    7. Manage Cleaning Verification Program
    8. Manage validation document filing and storage system
  3. General Duties  
    1. Facilitate and/or support validation training
    2. Manage projects as required
    3. Manage the Annual Product Review (APR) including validation and change control
    4. Manage periodic review of validated systems, equipment, cleaning and processes
    5. Support change management
    6. Member of the Change Management Core Team
    7. Member of USP Water Mediation Team

 

4.Department Leadership

  1. Sets directions for the Validation Department and Managed the Validation Engineering Team. 

 

QUALIFICATIONS

 

  • Bachelor degree required, advanced degree preferred. 
  • Minimum of 5 years in pharmaceutical industry (Process Development, Technology Transfer, Operations, Quality Assurance).  Previous work experience should include exposure to a broad range of Pharmaceutical Validation activities such as document control, information technology, production record review,GMPCompliance, Computerize System Supplier Assessment, validation, change control, etc. 
  • Experience in leading and/or managing validation activities a must.

 

GMP DECISION-MAKING AUTHORITY

 

  1. Has authority to assign validation strategy/assessment for compliance/GMPcapability.
  2. Has approval authority for procedures, protocols, reports and change controls.

 

EOE/M/F/Vet/Disability