Quality Assurance Rep (2nd) in Wabash, IN at Apex Life Sciences

Date Posted: 7/16/2018

Job Snapshot

Job Description


Position: Quality Assurance Rep

Shift: 2nd shift, (3:30pm – 2am, M-Th)

Location: Fort Wayne, IN

Summary: Apex Life Sciences has a full time, permanent need for a Quality Assurance Representative for our client in the consumer product industry. This position is one of high regulatory responsibility that provides direct quality oversight for the cGMP production of Dietary Supplements and other food products at the client. This position will help ensure compliance to SOPs, batch records, master manufacturing records, and to 21 CFR Part 110 and 111.  

Duties/Responsibilities: 

  • Understand and assist in maintaining compliance to FDA Regulations 21 CFR 110 and 111 for food and DS and other global food regulations as needed
  • Execute the batch disposition process for raw materials, components and finished products
  • Lead investigations for quality related issues through non-conformance and deviation systems, CAPA process
  • Interpret and implement quality assurance standards/SOPs effectively and accurately
  • Mentor the Quality Specialist performing batch record review process
  • Assist and/or Lead internal audits and regulatory audits as directed by management
  • Assist with equipment qualification and process validation as needed
  • Provide oversight to the calibration process
  • Provide oversight of the change control process
  • Perform complaint investigations
  • Gather, trend, and assess data and maintain metrics for Quality Assurance
  • Train, support and mentor QC Inspectors that assist in providing direct production oversight
  • Other projects as directed by the Quality Manager

Qualifications/Experience: 

  • Possess a Bachelor’s Degree in a science, engineering or related field
  • Minimum of 2-5 years of relevant work experience in a cGMP manufacturing environment such as pharmaceutical, biotech, medical device, food or dietary supplement industries 
  • Demonstrated ability of applying cGMP requirements in a manufacturing environment effectively and logically
  • Prior experience with regulatory audits is a plus
  • Demonstrated ability to multitask and self-manage
  • Excellent written and verbal communication skills
  • Ability to effectively interact with individuals at all levels
  • Must have excellent computer skills