QA Specialist I - Validation & CAPA Focus

Coating Place, Inc.; Verona (WI); Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

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

Disability Insurance

Job summary

Coating Place, Inc. in Verona, WI, is seeking a QA Specialist I to support validation activities, product release, investigations, deviations, CAPA programs, and quality system tasks.

The role requires a BA/BS in life or physical sciences and 7+ years in Quality/Regulatory roles within FDA/cGMP environments. Candidates should have strong communication skills and be detail-oriented, able to work independently and with teams.

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).
• 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, aware of Halal and/or Kosher requirements.
• Other duties as assigned.

Skills

Written communication

Verbal communication

Interpersonal skills

Attention to detail

Teamwork

Independent work

Education

BA/BS in life or physical sciences

Tools

Microsoft Word

Excel

SharePoint

Acrobat Pro

Job description

Coating Place, Inc. in Verona, WI, is seeking a QA Specialist I to support validation activities, product release, investigations, deviations, CAPA programs, and quality system tasks.

The role requires a BA/BS in life or physical sciences and 7+ years in Quality/Regulatory roles within FDA/cGMP environments. Candidates should have strong communication skills and be detail-oriented, able to work independently and with teams.