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Quality/Regulatory Associate
Verona, WI
Job Description
Our Company:
Coating Place, Inc. has been in the contract manufacturing industry for the last 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.
Position Overview
The primary role of the Quality/Regulatory Associate position is to assist with preparation and maintenance of Annual Drug Product Reviews, and compilation and maintenance of Site and Drug Master Files and related applications. The Quality/Regulatory Associate will also assist by supporting Investigation, Deviation, and CAPA programs.Coating Place, Inc. has been in the contract manufacturing industry for the last 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.Position Overview
Essential Job Functions
- Support documentation for submission complies with pertinent regulations, company SOPs, and federal and international regulatory guidelines (e.g., ICH and GMP).
- Support compliance/regulatory review of documents (SOPs, protocols, and reports), as necessary.
- Support the Investigations, Deviations and CAPA programs.
- Assist with preparing Annual Drug Product Reviews, Site and Drug Master Files and annual GDUFA notifications and updates.
- Participate in Quality Systems improvement projects.
- Assist with support responses to questions and/or concerns from regulatory agencies within the time-frames specified.
- Assist with maintaining regulatory timelines and track deliverables to ensure regulatory submission timelines are met.
- Coordinate with CPI's functional areas and external support (e.g., contract laboratories) to request and obtain data relevant to submissions.
- Participate in the change control process and contribute to decisions regarding submission mechanism and documentation requirements to support proposed changes.
- Liaise with client and project managers/scientists support on NDA, ANDA, and CMC section filings.
- Continually monitor newly published FDA guidelines and international guidance documents and provide training on applicable requirements for staff, as required.
- Assist in authoring required regulatory/compliance statements.
- Maintains compliance with all company policies, plans, and procedures, including safety, security, and regulatory.
- Assists with Quality and Supplier audits.
- Other duties as assigned.
Education/Skills/Knowledge Required
- Associate or Technical degree in a science field required. BA/BS degree in life or physical sciences preferred (e.g., Pharmaceutical Sciences, Chemistry, Analytical or other relevant disciplines).
- Experience in Quality, Compliance and/or Regulatory Affairs preferred, but not required.
- Experience in a FDA and cGMP environment. Experience in a cGMP pharmaceutical environment preferred, but not required.
- Understanding of FDA 21 CFR regulations, ICH Guidelines, EU and Canadian GMPs.
- Proficient in Microsoft Word, Excel, SharePoint, and Acrobat Professional.
- Excellent 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
Start Date
As Soon As Possible
Employment Term and Type
Regular, Full Time
Hours per Week
40
Work Hours (i.e. shift)
1st Shift
Salary and Benefits
Based On Experience
A wide range of competitive benefit plans including company paid health and dental insurance premiums; Generous paid time off programs to help balance work and family life; Pre-tax 401(k) and after-tax Roth 401(k) contribution options. Company match 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, Inc., may choose to make a profit sharing contribution to your account.
Required Education
Associate Degree
Required Experience
Open
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