Quality Assurance Specialist / Sr. Specialist

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 Specialist / Sr. Specialist to work within our QA Operations team. This role will primarily manage/support Precigen's Gene Therapy Manufacturing program.

In this role, you'll ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and receipt / shipment of material through the creation and execution of a formal QA walkthrough and internal Audit program. These activities may result in additional training, recommendations for procedural improvements, or further investigation.

Increase quality culture in the manufacturing areas by partnering with manufacturing operators and management. Coach manufacturing team by providing positive and constructive feedback.

This will be an onsite role in our Germantown, Maryland facility.

DUTIES AND RESPONSIBILITIES:

• Responsible for the Quality support functions associated with manufacturing commercial drug substance batches
• Support the development and launch of the QA walkthrough and audit program.
• Establish QA presence on the manufacturing floor by performing process monitoring, real-time reviews, technical coaching of manufacturing personnel as needed, and act as QA's first responder to any potential process deviations.
• Own and execute QA walkthroughs and audits of the manufacturing areas.
• Documentation of findings and support area improvements / finding resolutions.
• Provide coaching to any QA personnel performing walkthroughs or audits during manufacturing operations.
• Perform area/line clearances.
• Review internal drug substance and buffer batch records and logbooks as required.
• Review and approve Quality Events (CAPA, Deviation, Change Control) as required.
• Create, revise, review and/or approve create QA on the floor procedures.
• Owns the execution of efficiency improvement projects with support from Management and cross-functional team members.
• 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:

• BS/BA degree in a scientific/life sciences discipline and minimum four (4) years of QA experience in a pharma/biotech/medical devices environment.
• Firm understanding of principles and practices of cGMP.
• Experience in QA support of biologics manufacturing and compliance; experience in Gene Therapy and/or Cell Therapy is a plus.
• Experience in commercial cGMP environment is a plus.

DESIRED KEY COMPETENCIES:

• Ability to work on-site.
• Desire to learn and develop a variety of QA competencies in a fast-paced environment.
• Commitment to professional and personal growth.
• Communicates clearly and effectively.
• Ability to execute responsibilities without oversight, and to manage multiple deadlines.
• Exhibition of the highest degree of ethical standards and trustworthiness.
• Strong interpersonal skills