QA Associate III - Second Shift (2-10)

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 40,845 - 45,956; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

PCI Pharma Services in San Diego is seeking a QA Associate III to support GMP operations on the second shift. You will perform QA activities, assist with investigations, batch disposition, and review documentation to ensure cGMP compliance.

Responsibilities include audits support, writing procedures, updating ERP lot statuses, and coordinating with production for compliant batch release. Bachelor’s in Life Sciences preferred with 3–5 years in QA/manufacturing. Competitive benefits offered.

Qualifications

• Minimum of 3–5 years of GMP experience in documentation, QA on the floor, manufacturing, or equivalent.
• Knowledge of cGMP regulations and good documentation practices.
• Strong organizational and analytical skills.
• Proficiency with Microsoft Office.

Responsibilities

• Assist with audits and regulatory inspections.
• Generate and compile lot file review documentation for batch disposition.
• Review and approve production batch records and controlled documents.
• Support investigation activities related to quality events.
• Maintain equipment inductions and change controls.
• Prepare procedures and SOPs.
• Update lot status in ERP.

Skills

GMP compliance

cGMP regulations

Quality investigations

Documentation control

ERP systems

Microsoft Office

Batch record review

Education

Bachelor’s degree in Life Sciences

Tools

ERP system

Documentation management software

Job description

## QA Associate III - Second Shift (2-10)Applylocations: San Diego, CA, USAtime type: Full timeposted on: Posted 4 Days Agojob requisition id: JR118508Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.**We are PCI.**Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.**SUMMARY:**This position is responsible for performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with applicable Quality Assurance (QA) and regulatory requirements, including assisting with audits, training programs, and documentation review in support of GMP operations. Promotes a compliant cGMP environment and follows SOPs. Provides quality support for investigations related to quality events associated with GMP manufacturing operations. Generates documentation and ensures completeness for batch disposition and batch record packet assembly. Ability to work independently, within prescribed guidelines, and as a team member. Leads projects and trains junior staff.**ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:*** Assists in regular follow ups with end users to ensure timely completion of open investigations and investigation activities.* Assist in ensuring the adequacy of investigations performed in relation to manufactured drug product and drug substance to support the batch release process.* Provides quality support in the review and approval of quality reports including deviations, OOSs, complaints, OOTIs, SCARs, and corrective and preventive actions (CAPAs)* Generates and compiles lot file review documentation for batch disposition.* Updates lot status in ERP system.* Responsible for equipment inductions, revisions and record maintenance within the electronic database.* Performs Technical Quality review of validation protocols and reports.* Performs logbook documentation audits for cGMP regulated logs and SOPs.* Creates, revises and approves procedures.* Performs the review of equipment and facility related Change Control documentation.* Assists with internal, client and regulatory audits.* Assists with the generation of department metrics.* Assists with developing recommendations for continuous improvement projects.* Assists in the review and approval of production batch records and associated data for product disposition.* Assists in the review and approval of controlled documents including standard operating procedures, protocols, and reports.* Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].* Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.* Fosters a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.* Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.**EDUCATION AND EXPERIENCE:*** High School Diploma or equivalent. Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.* Minimum of three to five (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.* Must be familiar with Microsoft Office applications.The hiring rate for this position is $29.65 - $33.36/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).#LI-AK2Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future**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.*