QA Specialist I

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

QA Specialist I

Verona, WI, US

**$2,000 Sign-On Bonus!**

1st Shift: 8:00am – 5:00pm, Mon - Fri

Position Overview

The primary role of the QA Specialist I position is supporting validation activities, product release, Investigations, Deviations, CAPA programs, and a variety of quality system activities.

Essential Job Functions

• 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.

Education/Skills/Knowledge Required

• 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.

Competitive Benefits:

• Friendly work environment.
• Medical, Dental, Vision, Life, AD&D, and Disability Insurance.
• Pre-tax 401(k) and after-tax Roth 401(k) contribution options with company matching up to 5%.
• Generous Paid-time Off - Accrue up to 17 days of PTO within the 1st year.
• Tuition Reimbursement Program.
• Sign-On Bonus!