Quality Regulatory Specialist (Manufacturing)
Quality Regulatory Specialist (Manufacturing)
TargetCW
Hercules, CA
Job ID : 2f67505a53335a347856647a79512b4254413d3d
Job Description :
Please note: This role requires vaccination under current guidance applicable to the company. As such, absent an approved accommodation based on a religious or medical reason, employees in this role will be required to be fully vaccinated from COVID-19 prior to starting work.
Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives. They are looking for Quality Regulatory Specialist (Manufacturing) to assist the Northern California Quality Assurance Operations team in support of manufacturing activities including, supporting product nonconformance and deviations, product quality holds as well as batch record and general label review and release.
How You'll Make An Impact:
- The Quality Systems Specialist will play a key role in supporting manufacturing activities at the Life Science Group site on the Hercules campus.
- Activities will primarily include supporting product release and process nonconformance and deviation management including follow-up & liaison with applicable department assignees.
- Perform activities related to batch record review, product release, assisting with document inquiries, SAP transactions, and posting of CofAs.
- Review and compile device history records for accuracy and completeness, and to ensure adherence to in-house specifications and regulatory requirements and document deviations as appropriate.
- Maintain and archive controlled documentation and completed quality records as needed.
What You Bring:
- Associate degree or equivalent in Biology, Chemistry, or related field.
- 2+ years’ experience in Quality/Regulated Manufacturing industry supporting nonconformance and deviations, product quality holds, batch record and general label and review release.
- Must have experience to perform activities related to batch record review and product release
- Understanding of GMP and quality system standards as they apply to products manufactured by company
- SAP experience a plus or similar
- Experience with QMS Databases (i.e., EtQ, Trackwise).or similar
- Some working knowledge of device/drug/biotech manufacturing processes or similar.
Please submit your resume for consideration. Thank you!
TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.
Company Details :
Name : TargetCW
CEO : Samer Khouli
Headquarter : San Diego, CA
Revenue : $500 million to $1 billion (USD)
Size : 51 to 200 Employees
Type : Company - Private
Primary Industry : HR Consulting
Sector Name : Human Resources & Staffing
Year Founded : 2009
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Details
: Hercules, CA
: 42 USD HOURLY
: Today
