Overview
Quality Technician – 2nd Shift Jobs in Thomson, GA at Adler Pelzer USA
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:
BS/BA degree in a scientific/life sciences discipline and minimum four (4) years of QA experience in a pharma/biotech/medical devices environment.
Solid knowledge of principles and practices of cGMP.
Experience in QA support of biologics manufacturing and compliance; experience in Raw Materials disposition is a plus.
Experience in commercial cGMP environment.
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
EOE MFDV
Title: Quality Technician – 2nd Shift
Company: Adler Pelzer USA
Location: Thomson, GA
