Suffolk is Educated

QA Specialist/Complaints

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 QA Specialist is responsible for investigations related to quality events received from customer/consumer complaints. Responsibilities include, but are not limited to:

- Receiving, logging, categorizing, tracking and investigating customer complaints and inquiries. 
- Prepare written responses for complaints received and provide direct correspondence with the customers/consumer as required. 
- Determine the appropriate CAPA relating to the quality event, if required, with the collaboration of the associated Operational group, and follow through until implemented. 
- Coordinate the initiation, review, and approval process (including customer approval if required by Quality Agreement) of complaints through the Quality Management System.
- Assist with tracking and investigating product, packaging, or shipping non-conformities.
- Assist with deviations, as needed.
- Assist with change controls, as needed.
- Provide training to employees on any relevant procedures related to any CAPAs generated from complaints, as needed.
- Review/approve and/or author documentation such as protocols, SOPs, forms, and reports, as needed.
- Quality Assurance sign-off authority for SOPs and other cGMP documentation, as needed. 
- Provide QA support to various departments, as needed.
- Other responsibilities as assigned by Senior Management

Qualifications

  • Requirements:
  • - Bachelor's degree required with three years experience in pharmaceutical quality assurance and validation.
  • - High School diploma with a minimum of eight years’ work experience in validation and/or quality assurance in lieu of college degree
  • - Top-notch organization skills
  • - Excellent verbal and written communication skills

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Job Snapshot


Type:

Full Time

Posted:

1/11/19

Company Snapshot


Company:

Contract Pharmacal Corp.

Location:

Hauppauge, NY

Industry:

Pharmaceuticals

Established:

1971

Website:

www.CPC.com