What are the responsibilities and job description for the QA Associate, Clinical Studies position at Abacus Service Corporation?
Description / Comment : ADDRESS - Ware Court, San Diego, CA - DURATION - MONTHS - SHIFT - MON-FRI AM - : PM - ONSITE POSITION. POSSIBLE TEMP TO HIRE IF SALES CONTINUE TO GROW.
I. Position Overview :
Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Follows established protocols and work plans. May be assisted by QA Specialists and Sr. Specialists. Comply with divisional and site Environmental Health and Safety requirements.
- Essential Functions :
- Responsible for inspection of incoming materials for GMP production
- Assist with packaging floor activities for primary and secondary (equipment / room approval, facility compliance, auditing, label inspection, line clearance, etc.)
- Reviews production batch records, logbooks and other associated documents
- Performs Quality verification of just-in-time labeling activities
- Performs document issuance, scanning, filing and archival activities
- Revises SOPs, Work Instructions and Forms pertaining to their area of focus, as needed
- Assists in the execution of efficiency improvement projects with guidance
- Ensures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs
- Participates in Quality programs, procedures and controls to ensure that products conform to established standards and agency guidelines
- Ensures gathering of data, investigations and deviations are timely and compliant
- Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
- Respond and interact with internal and external clients in a professional and timely manner
- All other duties as assigned
III. Position Requirements :
Education or Equivalent : Associate's degree or equivalent knowledge and experience.
Experience : Six Sigma or ASQ certification preferred.
Knowledge / Skills Requirements :
CSD-JD-QA Associate – Clinical Supplies
Physical Requirements :
Business Environment :
