QA Specialist I
QA Specialist I
Shift
The shift hours and days for this position are 4pm – 4am Thursday – Saturday, rotating Sunday (see below)
- Thursday, Friday, Saturday – 3x12 shift (4pm to 4am)
- Rotation – Every other Sunday (4pm to 4am)
Essential Functions:
- Will provide on the floor QA oversight and support to ensure compliance of GMP activities throughout the site.
- Direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address compliance issues and questions real time.
- Ensures adherence to proper escalation when non-conformances are identified as outlined per applicable procedures.
- Serves as a resource for compliance, escalation and corrections.
- Ensure departmental compliance to procedures, gmp records and associated forms.
- Ensures documentation is recorded in accordance with ALCOA principles.
- Work with operating entities with guidance from senior colleagues to ensure that inspections, statistical processes control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- May assist with investigations and corrective and preventive actions (CAPA).
Knowledge, Experience & Skills:
- 2+ years of relevant experience in a GMP environment related field and a BS. OR 3+ years of relevant experience and an AA degree.
- Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates basic knowledge of FDA standards and quality systems.
- Demonstrates good verbal, written, and interpersonal communication skills.
- Demonstrates working knowledge in Microsoft Office applications.
- Demonstrates basic knowledge of FDA standards and quality systems.
- Biopharmaceutical or Pharmaceutical experience preferred.
Shift
- Thursday, Friday, Saturday – 3x12 shift (4pm to 4am)
- Rotation – Every other Sunday (4pm to 4am)