QA Specialist II - Raw Materials

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JOB DESCRIPTION:

Position Title: QA Specialist II - Raw Materials

Location: Bedford, NH

Department: Quality Control

Reporting To: Quality Assurance Ops

Responsible For (Staff): No

The QA Specialist II- Raw Materials is responsible for providing QA oversight to the Materials Management workstream and associated tasks across the Bedford, NH site. Primarily responsible for 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 QA Specialist II - Raw Materials assists with the initiation and review of raw material quality systems, material specifications 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, and Supplier Quality daily.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide QA oversight to Materials Management and Quality Control, ensuring that site SOP's andraw material specifications are adhered to.
• Review and approve internal and external documentation associated with incoming raw materials, components, chemicals, excipients, and Active Pharmaceutical Ingredients (API).
• Responsible for the review and analysis of test results; ability to interpret and comprehendscientific information and data related to QC Micro and QC Analytical testing.
• Perform activities associated with the review, approval, and disposition of raw materials.
• Assist in the identification, isolation, and containment of potentially nonconforming materials.
• Review and approval of quality systems associated with raw material investigations
• Assist in the identification and management of expired materials; support scrapping of materials.
• Support Materials Management and Project Management with finished product shipments.
• Provide QA consultation and approval of new and revised raw material specifications.
• Support QA activities associated with incoming raw materials, including verification of associatedsamples, verification of appropriate AQL sample sizes and levels, and review of incoming raw material visual inspection activities and documentation.
• Ensure that raw materials are dispositioned appropriately to support production scheduleadherence; escalate concerns when there are potential conflicts.
• Prepare, review, approve, 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 inspectioncriteria align with vendor specifications.
• Provide Quality oversight of Quality Control laboratory spaces and Materials Managementwarehouse and storage areas, including review of area and equipment logbooks, and temperature monitoring data.
• Maintain and evaluate current processes and procedures. Identify and initiate opportunities forcontinuous improvement.
• Support the identification and segregation of materials associated with internal and external product recalls.
• Support internal, external, and regulatory audits.
• Train new and less experienced colleagues.
• Some interaction with clients through electronic communications and meetings to consult on therequirements of raw material testing.

QUALIFICATIONS:

Required:

• Bachelor's Degree in a relevant scientific field.
• Minimum 3 years' experience in related GMP industry working in Quality Assurance, Quality Control, or groups which support receipt, inspection, or release of materials in a pharmaceutical or biotechnology facility preferred.
• Equivalent combination of education and experience considered.
• Familiarity with USP and EP pharmacopoeias, and pharmaceutical raw material compendialtesting
• Knowledge and ability to apply basic scientific principles to solve operational and quality tasks
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as EU, ICH

Preferred:

• Exceptional organizational skills and attention to detail
• Excellent interpersonal and communication skills, and the ability to communicate well orally andin 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

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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.