QA Compliance & Training Specialist

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

Benefits offered by this job

Paid time off

Health insurance (medical, dental, and

401(k) plan

Flexible spending account

Job summary

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

This full-time role reports to the Quality Manager and involves document control, training administration, product and material release, audits, CAPAs, and continuous improvement initiatives.

Qualifications

• University/college education in math or science or relevant practical experience.
• Math skills required.
• Knowledge and experience with manufacturing processes and products.
• Excellent attention to detail and proofreading ability.
• Sound judgement when approving or rejecting work per specs and QC standards.
• Effective interpersonal skills and ability to influence and negotiate feedback.
• Computer proficiency with Access, Word, Excel, Internet, and ERP software.
• Strong organizational and time management skills to meet deadlines.

Responsibilities

• Independently perform product lot disposition by reviewing packaging records for completeness and compliance.
• Own and execute document control activities within the eQMS, including issuance, revision, and archiving.
• Coordinate and maintain the site training program, tracking GMP training curricula.
• Oversee onboarding and training for new hires, ensuring timely GMP and OJT completion.
• Deliver GMP and procedural training sessions as required.
• Monitor training compliance metrics and follow up on overdue training.
• Collect, analyze, trend, and report document control and training metrics.
• Maintain inspection readiness for training and document control systems.
• Lead or support continuous improvement initiatives to enhance quality systems.

Skills

Math skills

Manufacturing knowledge

Attention to detail

Sound judgement

Interpersonal skills

ERP experience

Time management

Education

University/college degree in math or science

Tools

ERP system

Job description

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

This full-time role reports to the Quality Manager and involves document control, training administration, product and material release, audits, CAPAs, and continuous improvement initiatives.