QA Specialist I: Compliance & Validation (Sign-On Bonus)

COATING PLACE LLC; Verona (WI); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

AD&D Insurance

Disability Insurance

401(k)

Job summary

COATING PLACE LLC in Verona, Wisconsin is seeking a QA Specialist I to support validation activities, product release, investigations, deviations, CAPA programs, and quality system tasks. The role requires strong regulatory understanding and attention to detail.

Ideal candidates will have a BA/BS in life or physical sciences and extensive experience in FDA/cGMP environments, superb communication skills, and the ability to work independently or in a team.

Qualifications

• BA/BS degree in life or physical sciences preferred.
• 7+ years in Quality, Compliance and/or Regulatory Affairs preferred.
• Experience in FDA and cGMP environment preferred.
• In-depth understanding of FDA 21 CFR, ICH Guidelines, EU/Canadian GMPs.
• Proficient in Word, Excel, SharePoint and Acrobat Pro.
• Strong written, verbal, interpersonal communication skills.

Responsibilities

• Provide compliance/regulatory document reviews (SOPs, protocols, reports).
• Support Investigations, Deviations and CAPA programs.
• Assist in preparing Annual Drug Product Reviews.
• Participate in Quality Systems improvement projects.
• Respond to regulatory questions within specified timeframes.
• Participate in validation activities.
• Assist in preparing regulatory/compliance statements.
• Maintain compliance with company policies and procedures.

Skills

Attention to detail

Written & verbal communication

Teamwork

Independent work

Relationship building

Education

BA/BS in life or physical sciences

Tools

Microsoft Word

Excel

SharePoint

Acrobat Pro

Job description

COATING PLACE LLC in Verona, Wisconsin is seeking a QA Specialist I to support validation activities, product release, investigations, deviations, CAPA programs, and quality system tasks. The role requires strong regulatory understanding and attention to detail.

Ideal candidates will have a BA/BS in life or physical sciences and extensive experience in FDA/cGMP environments, superb communication skills, and the ability to work independently or in a team.