QA Associate I: On-the-Floor cGMP Quality Champion

PCI Pharma Services; San Diego (CA); Presencial; USD 30 000 - 34 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid time off

Health insurance (including dental &.,

Resumo da oferta

PCI Pharma Services in San Diego seeks a QA Associate I to perform QA documentation review, ensuring adherence to cGMP requirements on the production floor and maintaining complete, accurate records.

The role supports change controls, investigations, and real-time QA oversight during manufacturing, with a start time around 7AM or 8AM and full-time hours. This entry-level position welcomes 0–2 years in QA or documentation, with a high school diploma and Life Sciences degree preferred.

Qualificações

• High School Diploma or equivalent required; Life Sciences degree preferred.
• 0–2 years in documentation, QA, or related.
• Knowledge of cGMP regulations and GDP preferred.
• Experience with CMMS preferred.
• Ability to follow detailed directions in a laboratory environment.
• Ability to work independently and as a team member.

Responsabilidades

• 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.
• Sterile gown qualified to support cGMP activities in sterile suites.
• Assists in the review and data entry of Calibration and Preventative Maintenance records.
• Assists in the review of equipment and facility related Change Control documentation.
• Maintains equipment files and archives.
• Regular and reliable attendance on a full-time basis.
• 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.
• Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.

Conhecimentos

cGMP knowledge

Documentation

Attention to detail

Teamwork

Independent worker

Formação académica

High School Diploma or equivalent

Bachelor's degree in Life Sciences

Ferramentas

CMMS

Descrição da oferta de emprego

PCI Pharma Services in San Diego seeks a QA Associate I to perform QA documentation review, ensuring adherence to cGMP requirements on the production floor and maintaining complete, accurate records.

The role supports change controls, investigations, and real-time QA oversight during manufacturing, with a start time around 7AM or 8AM and full-time hours. This entry-level position welcomes 0–2 years in QA or documentation, with a high school diploma and Life Sciences degree preferred.