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Senior Talent Acquisition Specialist at Independent Solution | Hiring for Pharma & Biotech | Expert in Global Sourcing
QA Operations Specialist (Shift)
Role Description:
This is a shift role with 4 extended 12-hour workdays followed by 4 days off.
The QA Operations Specialist provides direct support to the production area, ensuring the quality and compliance of products. The role involves reviewing process documentation for accuracy, completeness, and compliance with Good Manufacturing Practices (cGMPs). The Specialist also helps investigate any deviations and ensures that the documentation is completed correctly the first time. They spend significant time on the shop floor, offering guidance and coaching to maintain compliance and ensure quality.
Role Responsibilities:
* Review and approve Master Batch Records and Electronic Batch Records
* Ensure accuracy and compliance of production documentation
* Support compliance and data integrity on the shop floor
* Review and approve SOPs, Work Instructions, and job aids
* Participate in resolving issues during the Tier process
* Support qualification and commissioning for new equipment and capital projects
* Provide quality support for ongoing activities like Change Management, Deviations, and CAPAs
* Assist in internal audits and regulatory inspections
* Collaborate with cross-functional teams on continuous improvement initiatives.
Experience, Knowledge & Skills (Required):
* At least 5 years of experience in GMP Manufacturing, Quality Assurance, or related areas.
* Expertise in QA operations within the biotech industry and understanding of regulatory requirements.
* Strong leadership, communication, and interpersonal skills.
* Ability to work collaboratively in a team environment.
Preferred:
* Experience with quality systems, pharmaceutical manufacturing, or laboratory processes.
* Strong analytical, critical thinking, and problem-solving skills.
* Ability to coach and mentor others.
* Familiarity with GMP documentation and shop floor auditing.
Qualifications & Education:
A Bachelor’s degree in a scientific or engineering field (preferred), or significant relevant experience in a related field.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance, Project Management, and Science
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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