Quality Assurance Associate (Compliance)

Quality Assurance Associate - Compliance will be responsible for quality assurance support of compliance activities for cGMP and GTP support operations. The Associate will be responsible for a diverse and challenging set of activities, related to setting and maintaining quality standards aligned with US FDA cGMP and/or cGTP regulations.

  • Review and disposition of all Batch Production Records and related support documentation compiled by Manufacturing, Quality Control, and Donor Eligibility groups for purposes of lot release
• Review and approval of Deviations, CAPAs, Complaints, and QC investigations. Candidate will assist in the generation of Quality System metrics for our various quality systems (Deviations, CAPAs, Complaints, Lot Release, etc.)
• Perform and participate in internal/external audits. Candidate will also have an integral role in regulatory audit preparedness
• Review and disposition of incoming raw materials documentation


• Requires a bachelor's degree in any life science, preferably in Biology and/or Chemistry, or equivalent combination of experience and education. The candidate must have training in cGMPs and/or cGTPs and relevant regulatory guidelines
• Must be familiar with relevant regulations; formal training and/or advanced courses is preferred
• Must have excellent interpersonal skills and the ability to communicate company policies and procedures clearly
• Candidate must have experience with Microsoft Office (i.e. Word, Access, and Excel) and database management systems
• Must have strong organizational and record keeping skills, and the ability to handle multiple projects
• Ability to work independently in fast-paced environment with little supervision
• Ability to adapt to constant change and work effectively in abstract environment
• Candidate must be motivated and detail-oriented

 

 


PREFERRED:

• Requires a minimum of 3 years experience in a regulated environment in cGMP or cGTP Quality Assurance, Quality Control, Compliance or Manufacturing


If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=500285-3-323