QA Shop Floor Specialist

QA Shop Floor Specialist

Requirements

• Bachelor’s Degree in Life Sciences or Engineering with 2-3 years’ experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements.
• Or 3 years or more of relevant experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements in lieu of degree
• Must have Aseptic Manufacturing and Quality Auditing Experience
• Has experience with Filling machines in Grade A
• Worked in a Microbiology laboratory or Aseptic Production/Manufacturing Facility environment
• Advanced knowledge of MS Office including Excel, PowerPoint, and Word.

Responsibilities

• Conduct QA Shop Floor Walkthrough and Audit based on schedule and assignment
• Documentation of appropriate findings and support area improvement
• Support the Lead and Manager to drive QA shop floor program and address concerns with manufacturing and driving quality improvements
• Mentoring and coaching QA Shopfloor personnel
• Coaching manufacturing team, when required
• Collaboration with manufacturing on process improvements
• Area/Line clearances, when required
• Review documentation- BPRs, Logbooks
• Deviation support, when required
• Perform audits, walk-throughs, GEMBAs, technical coaching
• Support Lead and Manager with tasks as needed (Change Control, Deviations etc)
• Support Additional Quality functions (Media Fill Observer, Documentation Updates etc)

Preferred Qualifications

• Packaging experience is preferred
• Decision making, auditing, and deviation investigations.
• Demonstrated willingness to learn, teamwork abilities, excellent communication, adaptability, organizational and analytical skills, and a strong interest in the pharmaceutical and bio-pharmaceutical industry.
• Must have excellent written and verbal communication skills