Quality Assurance Associate II, 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

The primary roles of the QA Associate II, Quality/Regulatory position include preparation and maintenance of Annual Drug Product Reviews, compilation of quality metrics, compliance/regulatory review of SOP’s, protocols, and reports, and support of the investigation, deviation, and CAPA programs.  

Essential Job Functions

* Prepare Annual Drug Product Reviews.

* Retrieve data and compile, tabulate, and report quality metrics by department and by product.

* Perform regular quality inspections of other departments (QA on the floor).

* Participate in internal audits.

* Provide compliance/regulatory review of documents (SOPs, protocols, and reports), as necessary.

* Support the Investigation, Deviation and CAPA programs, as necessary.

* Participate in Quality Systems improvement projects.

* Author required regulatory/compliance statements.

* Maintains compliance with all company policies, plans, and procedures, including safety, security, and regulatory.

* Support additional QA functions such as shipment release, batch record review, and analytical data review, as necessary.

* Other duties as assigned.

Education/Skills/Knowledge Required

* BA/BS degree in life or physical sciences preferred (e.g., Pharmaceutical Sciences, Chemistry, Analytical or other relevant disciplines).

* Minimum 2 years of experience in cGMP Quality, Compliance and/or Regulatory Affairs preferred. .

* Understanding of FDA 21 CFR regulations, ICH Guidelines, EU and Canadian GMPs preferred.

* Proficient in Microsoft Word, Excel, SharePoint, and Acrobat Professional.

* Outstanding written, verbal, and interpersonal communication skills required.

* Strong attention to detail.

* Ability to work independently and in a team.

* Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.

 

 

Job Summary
Employment Term and Type
Regular, Full Time
Hours per Week
40
Work Hours (i.e. shift)
8 AM - 5 PM
Required Education
Bachelor's Degree
Required Experience
2+ years
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