QA Supervisor - Raw Materials

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Position Title: Supervisor, QA Raw Materials

Location: Bedford, NH

Department: Quality Assurance Ops

Reporting To: Sr. Manager/Director of QA Operations

Responsible For (Staff): Yes

The Supervisor, QA Raw Materials is responsible for leading a team of QA Raw Material Specialists and providing QA oversight to the Materials Management workstream and associated tasks across the Bedford, NH site. Primary responsibilities of this team includes supporting Materials Management and Quality Control in the receipt of raw materials, review of internal and external raw material documentation, and disposition of raw materials. The position also assists with the initiation, review, and closure of raw material quality systems, material specification creation and revisions, and ensures adherence to site procedures and material specification receipt, testing, and release requirements. This position will actively partner with QA Operations, Materials Management, Quality Control, Project Management, Supplier Quality, and Procurement.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform review of external documentation and internal GMP documentation associated with incoming raw materials, components, chemicals, excipients, and Active Pharmaceutical Ingredients (API).
• Provide Quality Assurance oversight to Materials Management and Quality Control, ensuring that site SOP's and raw material specifications are adhered to.
• Responsible for the review and analysis of test results; ability to interpret and comprehend scientific information and data related to QC Micro and QC Analytical testing.
• Initiation, review, and disposition or closure of raw material quality systems
• Assist in the identification, isolation, and containment of potentially nonconforming materials
• Assist in the identification and management of expired material; perform scrapping of materials with Materials Management
• Assist Materials Management and Project Management with finished product shipments
• Provide input, review, and approval of new and revised raw material specifications.
• Support Quality Assurance activities associated with incoming raw materials, including verification of associated samples, verification of appropriate AQL sample sizes and levels, and review of incoming raw material visual inspection activities and documentation.
• Ensure that raw materials are reviewed and dispositioned appropriately to support production schedule adherence; escalate concerns when there are potential conflicts.
• Prepare, review, distribute, and reconcile raw material status labels.
• Support assessment of new components for defect criteria
• Interpret drawings, schematics, and diagrams of materials to ensure that all incoming inspection criteria align with vendor specifications.
• Provide Quality oversight of Quality Control laboratory spaces and Materials Management warehouse and storage areas, including review and inspection of areas, equipment logbooks, and temperature monitoring data.
• Support the identification, segregation, and review or closure of quality systems associated with recalled raw materials.
• Support internal, external, and regulatory audits.
• Lead and delegate daily team activities and provide coaching and coordination of daily tasks to team members.
• Support cross-functional projects and continuous improvement objectives.
• Interaction with clients when reviewing and approving client owned material specifications.
• Recommend and lead improvement ideas and projects
• Obtain Qualified Trainer status on department specific training tasks; train team members.
• Prepare, review, and facilitate team shift review material; Represent QA Raw Materials at cross-functional DDS meetings.
• Interact with members of senior management

QUALIFICATIONS:

Required:

• Bachelor's Degree in relevant scientific discipline with a minimum of 5+ years' experience in related GMP industry working in Quality Assurance or Quality Control groups which support receipt, inspection, or release of materials. Equivalent combination of education and experience considered.
• Prior experience leading teams is a plus.
• Knowledge of USP and EP pharmacopoeias, and pharmaceutical raw material compendial testing.
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as EU, ICH
• Ability to apply basic scientific principles to solve operational and quality tasks.
• Experience with RCA, technical writing, and working with quality related investigations.

Preferred:

• Exceptional organizational skills and attention to detail
• Excellent interpersonal and communication skills, and the ability to communicate well orally and in writing
• Proficiency in MS Office including Word, Excel, and Smartsheet
• Team oriented and ability to work collaboratively with others
• Highly attentive and organized with documentation
• Ability to work in a dynamic, fast-paced work environment
• Honesty, integrity, respect and courtesy with all colleagues
• Resilient through operational and organizational change
• Works with Materials Management, Quality Assurance, Quality Control departments on a daily basis
• Frequently work with Project Management and Supplier Quality
• Escalates raw material quality related concerns to Quality Management in a timely manner
• Some travel between local Bedford, NH buildings.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.