QA Associate I, Quality/Regulatory
Verona, WI 
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Posted 1 month ago
Job Description
OUR COMPANY:

Coating Place, Inc. has been in the contract manufacturing industry for over 40 years. Our continued goal to provide the highest quality Wurster processing has kept us at the forefront of the “fluid bed micro-encapsulation” market. Our company mission helps us to maintain this focus.

“Coating Place is an established pharmaceutical contract manufacturer specializing in Wurster fluid bed processing and delivery system development. We provide our customers with modified and extended release bulk active products through innovative development and manufacturing capabilities with an integrated quality philosophy.”

It is our mission to continue urging the next generation, candidates like you, into these fields and further expand the capabilities of the industry through their capabilities. 

Coating Place is a stable and growing company that offers a friendly work environment and an incredibly competitive benefits package including: health, dental, and vision insurance, a generous paid time off program to help balance work and personal life, and pre-tax 401(k) and after-tax Roth 401(k) contribution options with the company matching up to 5% of gross wages that is 100% vested at the time it is added to the employee’s account. In addition, Coating Place may choose to make a profit sharing contribution to your account!

Position Overview
Under the supervision of the QA Manager, the QA Associate will be responsible for performing data entry, generation of metrics, internal auditing, shipment release, and providing administrative support for the QA Department in a cGMP manufacturing environment.

Essential Job Functions
  • Accurately enter information into various databases/spreadsheets.
  • Process information – compile, sort, calculate, tabulate, audit, and verify information or data.
  • Participate in internal auditing activities (formal internal audits and QA on the floor).
  • Carry out shipment release activities.
  • Assist with annual drug product reviews (ADPR).
  • Complete Quality Control data review
  • Perform administrative support activities such as filing, scanning, etc. on an as needed basis.
  • Follow all CPI cGMP and safety practices, policies, and procedures.
  • Perform other duties as assigned.

Education/Skills/Knowledge Required
  • 1 -2 years pharmaceutical experience supporting cGMP manufacturing or 2 to 4 year college degree, preferred.
  • Demonstrated knowledge of cGMPs, FDA, or other regulatory agency requirements, preferred.
  • Proficiency in Microsoft Office, preferred.
  • Superior keyboarding skills.
  • Desire for accuracy, detail oriented.
  • Ability to work independently and achieve required expectations.
  • Ability to communicate both verbally and in writing across all levels of the organization.
  • Excellent organizational and multi-tasking skills and sound practice judgement of priorities and high attention to detail.
  • A continuous improvement and quality mindset.

 

Job Summary
Start Date
ASAP
Employment Term and Type
Regular, Full Time
Hours per Week
40
Work Hours (i.e. shift)
1st Shift
Salary and Benefits
Based on Experience
Required Education
High School or Equivalent
Required Experience
1+ years
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