QA Associate II

1 week ago

Verona, United States Coating Place Full time
QA Associate II
**$2,000 Sign-On Bonus**
1st Shift: 8:00am - 4:30pm, Mon - Fri

Our Company:

Coating Place is an established pharmaceutical contract manufacturer specializing in Wurster fluid bed processing and delivery system development. We provide our customers with modified and extended-release bulk active products through innovative development and manufacturing capabilities with an integrated quality philosophy.

Position Overview

The primary roles of the QA Associate II position include compilation of quality metrics, editing and review of SOPs, protocols, and reports, performing raw material and product release, and support of the investigations.

Essential Job Functions
  • Retrieve data and compile, tabulate, and report quality metrics.
  • Participate in internal audits.
  • Provide review of documents (SOPs, protocols, and reports), as necessary.
  • Support the Complaint, Incident, Deviation and CAPA programs, as necessary.
  • Participate in Quality Systems improvement projects.
  • Support drafting of quality statements and/or reports.
  • Maintains compliance with all company policies, plans, and procedures, including safety, security, and regulatory.
  • Support additional QA functions such as shipment release, batch record review, and analytical data review, as necessary.
  • 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
  • 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).
  • Minimum 2 years of experience in cGMP Quality, Compliance and/or Regulatory Affairs preferred.
  • Understanding of FDA 21 CFR regulations, ICH Guidelines, EU and Canadian GMPs preferred.
  • Proficient in Microsoft Word, Excel, SharePoint, and PDF programs.
  • 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.
Working Conditions

The QA Associate II primarily works in an office environment but may be required to perform work in a manufacturing and/or warehouse setting. Working in these environments may provide exposure to warehouse equipment, production equipment, electrical equipment, sharp instruments, and identified hazardous chemicals including controlled substances. Safety procedures and personal protective equipment and training are required.

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.

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