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Summary:

The QA Associate I, Raw Materials is responsible for proving Quality Assurance oversight to the Materials Management workstream and associated related tasks and subject matter 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.
• Assists with the initiation and review of raw material quality systems, material specifications, and adherence to site procedures and material specification receipt, testing, and release requirements.
• Actively partner with Quality Assurance Operations, Materials Management, Quality Control, Project Management, and Supplier Quality on a daily basis.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• 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.
• Assist in the initiation and review 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, reviewal, 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 so as 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 of area and equipment logbooks, and temperature monitoring data.
• Maintain and evaluate current processes and procedures and look for opportunities for continuous improvement.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• 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 works with Project Management and Supplier Quality
• Escalates any raw material quality related issue real time to Quality Management
• Some travel between local Bedford, NH buildings

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Able to communicate effectively
• Able to deal with ambiguity
• Able to translate ideas to actual concepts and processes
• Ability to manage multiple projects and tasks simultaneously
• Able to follow written instructions
• Lifting, pushing, pulling up to 20 pounds
• Sitting for long periods of time >50%
• Walking, standing, bending, stooping and kneeling <25% of the time.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• High School diploma or equivalent is a requirement
• AS/BS in a related field in a relevant scientific discipline is a plus

• 0-2 years' experience working in Quality Assurance, Quality Control, or Materials Management groups which support receipt, inspection, or release of materials in a pharmaceutical or biotechnology facility preferred.
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as EU, ICH
• Knowledge and ability to apply basic scientific principles to solve operational and quality tasks

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Join us and be part of building the bridge between life changing therapies and patients.

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.