Suffolk is Educated

QA Compliance Coordinator

Overview

The Coordinator of QA Compliance has primary responsibility for finished product labeling, ingredients list related regulations (FDA, Canada, EU, etc.), customer and supplier quality agreements, PPPA/container closure evaluation, and serving as the DEA Liaison Officer.

Description

Responsibilities include, but are not limited to: 

• Serve as the subject matter expert on all label/labeling and PPPA/Container Closure regulations as it pertains to CPC products (FDA, Canada, EU, etc.)

• Serve as the DEA Liaison Officer. This includes; being the primary CPC contact to the DEA, hosting DEA inspections, completing DEA annual reporting and quota requests

• Serve as the subject matter expert on DEA related items and support internal DEA regulatory activities

• Support Ingredient Lists (ILs) and Finished Product Specification Sheets (FPSS) including raw material research (COAs and raw material origin) and lead related continuous improvement projects 

• Manage customer and supplier quality agreements 

• Support and proof new/revised printed components (labels, IFCs, inserts, blisters, etc.)

• Manage building and state permits and licensing (Suffolk County, DEA, Fire Department etc.)

• Manage product and facility certifications for Organic, Gluten Free, Non-GMO etc.

• Assist in related QA Compliance / Regulatory items as needed 

• Support Regulatory and QA Compliance related customer requests as needed

• Perform MasterControl System Administrator functions

• Other projects and duties as assigned by Senior Management

Qualifications

  • Education and Experience:
  • • Bachelor’s degree in science, compliance, business or related required
  • • Education/Experience in the legal field a plus
  • • Two years’ work experience, preferably in an FDA regulated industry with minimum one year in quality assurance or
  • regulatory
  • Skills and Abilities:
  • • Knowledge of cGMPs related to US FDA and EU EMEA packaging environments
  • • Ability to read and interpret regulatory guidelines as they apply to label/labeling
  • • Proficiency in Microsoft Word, Excel, graphs/charts and databases
  • • Ability to communicate effectively, compile, manage and interpret data, strong technical writing skills

Apply Now

Job Snapshot


Type:

Full Time

Posted:

11/19/18

Company Snapshot


Company:

Contract Pharmacal Corp.

Location:

Hauppauge, NY

Industry:

Pharmaceuticals

Established:

1971

Website:

www.CPC.com