What are the responsibilities and job description for the Specialist / Sr. Specialist, QA Material Control position at Precigen, Inc?
Job Description
Job Description
Title : Specialist / Sr. Specialist, QA Material Control
POSITION SUMMARY :
Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.
Precigen is seeking a detail-oriented and skilled Quality Assurance Specialist / Sr. Specialist to support our QA Materials Management and Manufacturing teams. This role will primarily manage / support Precigen’s Gene Therapy Manufacturing program. The position works to ensure compliance with applicable regulations and company procedures / policies during manufacturing and QC testing operations.
This will be an onsite role in our Germantown, Maryland facility .
DUTIES AND RESPONSIBILITIES :
- Owns QA oversight of internal material control (receipt, quarantine, release, storage, inventory, intermediate control and shipment).
- Review and approval of raw material release documentation.
- Review and approval of raw material qualification documentation.
- Support in the development and improvement of current materials management and related QA procedures.
- Oversee critical material receipt and shipment.
- Logbook review.
- Performs, reviews, or approves deviations, change controls and CAPAs related to materials management / supply chain.
- Provides coaching to materials management personnel as necessary.
- Assists in the execution of efficiency improvement projects with guidance.
- Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and regulatory guidelines.
- All other duties as assigned.
EDUCATION AND EXPERIENCE :
DESIRED KEY COMPETENCIES :
EOE MFDV
