Job Title:
Quality Assurance Specialist – Sterile Manufacturing
Location: Onsite only
Shift: 4-cycle, 12-hour shifts
Job Summary:
The Quality Assurance Specialist provides support to production teams to ensure
cGMP standards
are consistently maintained. This role requires operational knowledge of sterile manufacturing, quality systems, and regulatory compliance.
Key Responsibilities:
* Support production teams to maintain cGMP compliance.
* Review batch documentation (EBRs), line clearances, and assist in resolving issues based on risk.
* Respond to unplanned events and technical issues promptly.
* Support audits, inspections, and maintain "Quality Right First Time" metrics.
* Conduct spot checks/walk-throughs of production lines.
* Participate in investigations, including customer complaints if required.
* Work cross-functionally to promote continuous improvement in quality standards.
* Utilize computerized systems such as SAP, MES, or Trackwise for daily tasks.
Qualifications & Experience:
* Bachelor's degree or higher in a Science discipline preferred.
* 2-3 years' experience in a
Quality role
in pharmaceutical manufacturing, preferably aseptic.
* Familiarity with
cGMP, GDP
, and regulatory requirements (EU, US, and international).
* Experience with SAP, MES, or Trackwise is desirable.
* Strong documentation, reporting, and compliance knowledge.
* Ability to prioritize tasks, manage multiple deadlines, and work effectively in a team.
Additional Requirements:
* Onsite role; remote/hybrid not applicable.
* Shift work experience in quality or aseptic manufacturing is beneficial.