QA Associate I — cGMP Compliance & Documentation

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); In loco; USD 29.000 - 33.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance (dental & vision)

Flexible spending account

401(k) plan

Paid time off

Descrizione del lavoro

PCI Pharma Services in San Diego is hiring a QA Associate I to perform routine and semi-routine QA activities, ensuring compliance with cGMP and GDP. The role includes documentation review, on-the-floor QA oversight, and collaboration with cross-functional teams to maintain quality standards.

The position requires a High School Diploma (Bachelor’s in Life Sciences preferred), 0–2 years in QA or documentation, knowledge of cGMP, and CMMS experience.

Competenze

• Zero to two years of relevant QA or documentation experience.
• Knowledge of cGMP regulations and good documentation practices preferred.
• Experience with CMMS is preferred.

Mansioni

• Performs cGMP documentation/data review (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records).
• QMS process support for change controls and quality investigations.
• Performs AQL inspection of final filled product.
• Performs area line clearance operations in support of manufacturing operations.
• Provides QA oversight and performs real time, on-the-floor documentation review during manufacturing operations.
• Generate labels for cGMP use.
• Reviews, approves, and reconciles labels for cGMP use.
• Maintains equipment files and archives.

Conoscenze

Documentation review

Quality Assurance

Detail orientation

Formazione

High School Diploma or equivalent

Bachelor’s degree in Life Sciences preferred

Strumenti

CMMS

Descrizione del lavoro

PCI Pharma Services in San Diego is hiring a QA Associate I to perform routine and semi-routine QA activities, ensuring compliance with cGMP and GDP. The role includes documentation review, on-the-floor QA oversight, and collaboration with cross-functional teams to maintain quality standards.

The position requires a High School Diploma (Bachelor’s in Life Sciences preferred), 0–2 years in QA or documentation, knowledge of cGMP, and CMMS experience.