QA Associate IPCI TRGR Penn Pharmaceutical Services Ltd • San Diego, California, United States

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QA Associate I

PCI TRGR Penn Pharmaceutical Services Ltd

San Diego, California, United States

San Diego, California, United States

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Über

Summary The QA Associate I is responsible for performing a wide variety of routine and semi‑routine activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements. The Associate I promotes a cGMP environment and collaborates with internal team members to ensure adherence to specifications, processes, and procedures. The Associate I performs documentation review and ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. Understanding and execution of basic cGMP and GDP principles is required. Job Responsibilities Performs cGMP documentation/data review (e.g., logbooks, cleaning logs, sterilization records, stability reports, buffer batch records). QMS process support for change controls and quality investigations. Performs AQL inspection of final filled product. Performs area line clearance operations in support of manufacturing operations. Provides QA oversight and performs real‑time, on‑the‑floor documentation review during manufacturing operations. Generates labels for cGMP use. Reviews, approves, and reconciles labels for cGMP use. Maintains sterile gown qualification to support cGMP activities in sterile suites. Assists in the review and data entry of Calibration and Preventative Maintenance records. Assists in the review of equipment and facility related change‑control documentation. Maintains equipment files and archives. Maintains regular and reliable attendance on a full‑time basis (or in accordance with posted schedule). Exhibits professional behavior with both internal and external business associates, reflecting positively on the company and in line with company policies and practices. Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture. Education & Experience High School Diploma or equivalent required. Bachelor’s degree in a Life Sciences discipline preferred. Zero to two (0‑2) years of relevant experience in documentation, QA, or equivalent. Knowledge of cGMP regulations and good documentation practices preferred. Experience with Computerized Maintenance Management Software (CMMS) preferred. Demonstrated ability to follow detailed directions in a laboratory environment preferred. Ability to work independently, within prescribed guidelines, and as a team member. Compensation and Benefits $21.69 – $24.41 per hour plus eligibility for an annual performance bonus. Full‑time employees receive a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Equal Employment Opportunity 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.
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San Diego, California, United States

Sprachkenntnisse

English

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