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

PCI TRGR Penn Pharmaceutical Services Ltd
  • US
    San Diego, California, United States
  • US
    San Diego, California, United States
Jetzt Bewerben

Über

Overview This role is responsible for ensuring compliance with Quality Assurance (QA) and regulatory requirements within GMP operations. The Primary responsibilities include audits, documentation review, training, and supporting investigations related to quality events. Responsibilities Assist in regular follow‑ups with end users to ensure timely completion of open investigations. Ensure adequacy of investigations performed for manufactured drug product and drug substance to support batch release. Provide quality support for the review and approval of quality reports, including deviations, OOSs, complaints, OOTIs, SCARs, and CAPAs. Generate and compile lot file review documentation for batch disposition and update lot status in the ERP system. Maintain equipment inductions, revisions, and records within the electronic database. Perform technical quality review of validation protocols and reports. Audit logbook documentation for cGMP‑regulated logs and SOPs. Create, revise, and approve procedures. Review equipment and facility related change control documentation. Assist with internal, client, and regulatory audits. Generate department metrics and assist in continuous‑improvement projects. Review and approve production batch records, associated data, and controlled documents (SOPs, protocols, reports). Lead projects and train junior staff. Maintain regular and reliable attendance on a full‑time basis. Qualifications High School Diploma or equivalent; Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent. 3–5 years of relevant GMP experience in documentation, QA on the floor, manufacturing, or equivalent. Knowledge of cGMP regulations and good documentation practices preferred. Strong organizational and analytical skills. Proficiency with Microsoft Office applications. Compensation $29.65 – $33.36 per hour plus eligibility for an annual performance bonus. Final offer amounts are determined by experience, education, credentials, geography, and subject‑matter expertise. Benefits Competitive benefits package including paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. Equal 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 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 purpose. We are committed to cultivating an inclusive workplace and hold ourselves accountable to the highest standards of fairness, respect, and equal opportunity at every level.
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  • San Diego, California, United States

Sprachkenntnisse

  • English
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