Suffolk is Educated

QA Document Control Manager

Overview

Overview

Contract Pharmacal Corp. (CPC) develops, manufactures and packages premium pharmaceuticals, over-the-counter drugs and dietary supplements. Owned and operated by the same family that founded the company in 1971, CPC today employs over 900 of the most highly skilled, experienced professionals in the industry and to date has commercialized over 4,000 products. For more company information, please visit www.cpc.com.

Description

The Document Control Manager is responsible for managing the review, release and retention process for documentation relating to the manufacturing and packaging of product based on cGMP standards and FDA guidelines; and must manage all related GMP documentation to ensure quick and easy access. Responsibilities include, but are not limited to:

- Mange the Document Control Department activities and personnel 
- Primary role for the release of bulk and finished product to market 
- Manage and create an organized environment for easy access to all documents in a timely manner
- Review completed product batch records for release and holds 
- Coordinate with cross functional teams to prioritize batch releases to meet customer delivery requirements
- Assist with product development projects
- Support all audits including but not limited to Regulatory Bodies (eg. FDA), Customer and Internal. 
- Create, assign and manage all operations log book 
- Create and Approve Certificates of Conformance (C of C’s)
- Review and Approve Change Controls
- Review and activate approved new and updated packaging specs and obsolete old packaging specs
- Other continuous improvement projects and duties as assigned by Senior Management

Qualifications

  • Requirements:
  • - Bachelor’s degree in Science, Business Management or related field
  • - Five years’ work experience, preferably in an FDA regulated industry with minimum three years in production or quality assurance
  • - Strong Good Documentation Practice and Good Manufacturing Practice skills
  • - Ability to read and interpret FDA guidelines as they apply to documentation
  • - Extensive knowledge of cGMPs related to US FDA and EU EMEA manufacturing environments
  • - Proficiency in Microsoft Word, Excel and graphs/charts
  • - Ability to communicate effectively, compile, manage and interpret data
  • - Strong technical writing skills

Apply Now

Job Snapshot


Type:

Full Time

Posted:

1/31/19

Company Snapshot


Company:

Contract Pharmacal Corp.

Location:

Hauppauge, NY

Industry:

Pharmaceuticals

Established:

1971

Website:

www.CPC.com