Quality Assurance Specialist: Document Control & Training

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

Benefits offered by this job

Health insurance

Flexible spending account

401(k) plan

Paid time off

Job summary

PCI Pharma Services is seeking a Quality Assurance Specialist (Document Control/Training) to ensure packaging, labeling, and distribution operations meet cGMP and internal quality standards. You will manage the eQMS, coordinate GMP training, and support audits and CI efforts.

Responsibilities include reviewing packaging records for disposition, maintaining training and document control readiness, and leading internal, supplier, and regulatory audits.

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 ERP.
• Excellent organizational, and time management skills to ensure deadlines are met.

Responsibilities

• Disposit product lots by reviewing packaging records for CGMP compliance.
• Own and execute document control in the eQMS, including issuance, revision, approvals, archival, and retirement.
• Coordinate and maintain the site training program, including GMP curricula.
• Onboard and train new hires ensuring GMP and OJT completion.
• Deliver GMP and procedural training sessions as required.
• Monitor training compliance metrics and overdue training.
• Collect and report document control and training metrics for continuous improvement.
• Maintain inspection readiness for training and document control systems.
• Lead or support continuous improvement initiatives and audits.

Skills

Math Skills

Interpersonal Skills

Time Management

Attention to Detail

Judgement

Organizational Skills

ERP

Access

Word

Excel

Internet

Education

Math/Science Degree

Tools

Access

Word

Excel

Internet

ERP

Job description

PCI Pharma Services is seeking a Quality Assurance Specialist (Document Control/Training) to ensure packaging, labeling, and distribution operations meet cGMP and internal quality standards. You will manage the eQMS, coordinate GMP training, and support audits and CI efforts.

Responsibilities include reviewing packaging records for disposition, maintaining training and document control readiness, and leading internal, supplier, and regulatory audits.