QA Specialist I — Regulatory & Validation Expert

Coating Place Inc.; Verona (WI); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Friendly work environment

Medical, Dental, Vision, Life, AD&D, &

Disability Insurance

Pre-tax 401(k) and Roth 401(k) with 5%

PTO 17 days (year 1)

Tuition Reimbursement

Sign-On Bonus

Job summary

Coating Place Inc. is seeking a QA Specialist I in Verona, WI to support validation activities, product release, investigations, deviations, CAPA programs, and multiple quality system activities. The role requires knowledge of FDA/cGMP guidelines and ability to interact with regulatory agencies.

The incumbent will review SOPs and regulatory documents, participate in audits and continuous quality improvements, and assist with regulatory submissions and annual reviews as required.

Qualifications

• BA/BS degree in life or physical sciences preferred (e.g., Pharmaceutical Sciences, Chemistry, Analytical or other relevant disciplines).
• 7+ years of experience in Quality, Compliance and/or Regulatory Affairs preferred.
• 7+ years of experience in a FDA and cGMP environment preferred.
• Experience in a cGMP pharmaceutical environment preferred.
• In-depth understanding of FDA 21 CFR regulations, ICH Guidelines, EU and Canadian GMPs.
• 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.

Responsibilities

• Provide compliance/regulatory review of documents (SOPs, protocols, and reports), as necessary.
• Support the Investigations, Deviations and CAPA programs.
• Assist in preparing Annual Drug Product Reviews.
• Participate in Quality Systems improvement projects.
• Support responses to questions and/or concerns from regulatory agencies within the timeframes specified.
• Participate in validation activities.
• Assist in preparing required regulatory/compliance statements.
• Maintains compliance with all company policies, plans, and procedures, including safety, security, and regulatory.
• Assists with Quality and Supplier audits, as needed.
• Employees at Coating Place work with and/or are familiar with the GMP requirements for Food, Dietary Supplements, Pharmaceuticals, or other elements of each.
• Depending on the position, the employee will be aware of Halal and/or Kosher requirements.
• Other duties as assigned.

Skills

Regulatory compliance

Quality assurance

Documentation review

Investigations & CAPA

SOPs & reports knowledge

Attention to detail

Teamwork & independence

Excellent communication

Education

BA/BS in life or physical sciences

Tools

Microsoft Word

Excel

SharePoint

Acrobat Professional

Job description

Coating Place Inc. is seeking a QA Specialist I in Verona, WI to support validation activities, product release, investigations, deviations, CAPA programs, and multiple quality system activities. The role requires knowledge of FDA/cGMP guidelines and ability to interact with regulatory agencies.

The incumbent will review SOPs and regulatory documents, participate in audits and continuous quality improvements, and assist with regulatory submissions and annual reviews as required.