QA Associate (I or II)

COATING PLACE LLC • Verona, WI

17h

About The Position

The primary roles of the QA Associate I position include performing review of raw analytical data, production data, protocols, summary reports, SOPs, internal analytical methods, and internal specifications. In addition, the QA Associate I will assist with data entry, generation of metrics, internal auditing, shipment release, and providing administrative support for the QA Department in a cGMP manufacturing environment.

Requirements

• 1-2 years pharmaceutical experience supporting cGMP manufacturing or 2 to 4 year college degree, preferred.
• Superior keyboarding skills.
• Desire for accuracy, detail oriented.
• Ability to work independently and achieve required expectations.
• Ability to communicate both verbally and in writing across all levels of the organization.
• Excellent organizational and multi-tasking skills and sound practice judgement of priorities and high attending to detail.
• A continuous improvement and quality mindset.

Nice To Haves

• Demonstrated knowledge of cGMPs, FDA, or other regulatory agency requirements, preferred.
• Proficiency in Microsoft Office, preferred.

Responsibilities

• Review laboratory notebooks, forms, and logbooks.
• Perform review or assist with drafting protocols, summary reports, methods, specifications.
• Create / Amend Certificate of Analysis.
• Accurately enter information into various databases/spreadsheets.
• Process information – compile, sort, calculate, tabulate, audit, review, and verify information or data.
• Participate in internal auditing activities.
• Carry out shipment release activities.
• Assist with annual drug product reviews (ADPR).
• Perform administrative support activities such as filing, scanning, etc. on an as needed basis.
• Follow all CPI cGMP and safety practices, policies, and procedures.
• Employees at CPI 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.
• Perform other duties as assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree