QA Specialist I

QA Specialist I

Essential Duties and Responsibilities:

Responsible for assisting the Quality Assurance Supervisor with department activities. Ensure compliance with regulatory requirements (e.g.cGMP) and site SOPs/Quality Agreements.

• Record and review data in compliance with applicable current Good Manufacturing Practices (cGMP) and company quality standards:
  • Perform batch record review.
  • Initiate, obtain approvals for, and complete documentation for change controls.
  • Conduct or assist in investigations for manufacturing/laboratory deviations and customer complaints.
  • Support the site CAPA system.
  • Perform incoming raw material/quality assurance release.
  • Perform Quality Assurance inspection tasks in support of material and product releases.
  • Establish and maintain Standard Operating Procedures as assigned.
  • Perform internal quality audits as assigned.
  • Author and/or provide supporting analyses for Annual Product Reviews.

• Perform assigned tasks on schedule according to standard operating procedures and supervisor instructions.
  • Maintain productivity and exhibit a good work ethic.
  • Perform assigned tasks on schedule according to standard operating procedures and supervisor instructions.
  • Maintain safe, clean, and organized work environment free from safety hazards.

• Support efforts for media fill batches.
• Suggests ways to improve overall quality.
• Perform other duties as assigned.

Education and/or Work Experience Requirements:

• B.S. degree in Chemistry, Biology, Engineering or a related field with 0 to 2 years of industry experience.
• Excellent time management skills and ability to work independently as well as in team collaboration.
• Excellent communication skills, organized with attention to detail.
• Successfully complete background check and drug screen.
• Proficient in Microsoft Office

Physical Requirements:

• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards.
• Must be able to occasionally lift and carry up to 50 lbs.
• Must be able to operate a computer and other office productive equipment, such as a calculator, copy machine, and a computer printer.
• Must be able to work in a noisy environment. (OSHA approved)