Quality Assurance Specialist - Document Control & Training

pciservices; San Diego (CA); On-site; USD 70,000 - 76,000; Full time

Benefits offered by this job

Paid time off

Health insurance coverage (including/d

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services in San Diego is seeking a Quality Assurance Specialist (Document Control/Training) to support packaging, labeling, and distribution operations while ensuring cGMP compliance and quality system requirements.

The role reports to the Quality Manager and entails document control in eQMS, training program administration, and ongoing quality metric tracking. Responsibilities include audits, CAPAs, and continuous improvement initiatives within a full-time framework.

Qualifications

• University/college education in math or science or relevant practical experience.
• Math Skills Required.
• Knowledge and experience with manufacturing processes and products.
• Exceptional attention to detail and proofing ability.
• Sound judgement when approving or rejecting work in keeping with specifications and internal quality control standards.
• Effective interpersonal skills and the ability to influence and negotiate in the presentation of feedback to colleagues and superiors.
• Computer knowledge to use software programs such as Access, Word, Excel, Internet, and custom company software, (ERP)
• Excellent organizational, and time management skills to ensure deadlines are met.
• Knowledge of GMP and pharmaceutical standards is an asset.
• Ability to multitask.

Responsibilities

• Independently perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance with cGMP requirements and company procedures with minimal supervision.
• Own and execute document control activities within the electronic Quality Management System (eQMS), including document issuance, revision, approval workflows, reconciliation, archival, and retirement activities, ensuring compliance with GDP and document control procedures.
• Coordinate, administer, and maintain the site training program, including assignment, tracking, and monitoring of GMP training curricula and periodic training requirements.
• Oversee onboarding and training activities for new hires, ensuring timely completion of required GMP and On-the-Job Training (OJT) requirements.
• Deliver and facilitate GMP and procedural training sessions as required to support employee competency and compliance.
• Monitor training compliance metrics and proactively follow up on overdue training assignments to maintain inspection readinesss.
• Collect, analyze, trend, and report document control and training quality metrics to support continuous improvement initiatives and management review activities.
• Maintain inspection readiness for training and document control systems, including timely retrieval of controlled documents and training records during audits and regulatory inspections.
• Lead or support continuous improvement initiatives to enhance quality system effectiveness, compliance, and operational efficiency.
• Support and participate in internal audits, supplier audits, customer audits, and regulatory inspections, including audit preparation, response coordination, and follow-up activities.

Skills

Math Skills

Attention to detail

Interpersonal skills

ERP

Organizational skills

Manufacturing knowledge

Education

University/college education in math or science

Tools

Access

Word

Excel

Internet

ERP

Job description

PCI Pharma Services in San Diego is seeking a Quality Assurance Specialist (Document Control/Training) to support packaging, labeling, and distribution operations while ensuring cGMP compliance and quality system requirements.

The role reports to the Quality Manager and entails document control in eQMS, training program administration, and ongoing quality metric tracking. Responsibilities include audits, CAPAs, and continuous improvement initiatives within a full-time framework.