Description:
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.
Catalent Pharma in San Diego, CA is hiring a Quality Assurance (QA) Associate, Clinical Supplies. Under general supervision, the QA Associate performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. The QA Associate follows established protocols and work plans and may be assisted by QA Specialists and Sr. Specialists. The QA Associate will comply with divisional and site Environmental Health and Safety requirements.
This is a full-time hourly position: Monday – Friday, 8am-5pm.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role:
- Responsible for inspection of incoming materials for GMP (Good Manufacturing Practices) production, and assist with packaging floor activities for primary and secondary packaging (equipment/room approval, facility compliance, auditing, label inspection, line clearance, etc.)
- Reviews production batch records, logbooks and other associated documents. Revises SOPs, Work Instructions and Forms pertaining to their area of focus
- Performs Quality verification of just-in-time labeling activities, document issuance, scanning, filing and archival activities
- Ensures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs (Standard Operating Procedures).
- 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. Assists in the execution of efficiency improvement projects with guidance
- Other duties as assigned
The Candidate:
- Associate’s degree or equivalent knowledge and experience is required.
- Six Sigma or ASQ certification preferred. Candidates with experience in a GMP QA setting will be favorably considered
- Must have the ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form
- Must be able to proactively address work issues at the individual and team level. Use mathematical and scientific reasoning ability to identify aberrant data and potential quality/compliance concerns escalating to management
- Must have the ability to collaborate with peers and demonstrate leadership capabilities in a matrix environment. Excellent written and verbal communications skills with internal and external customers, peers and managers required
- Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and fax machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business