Careers

CPL is a contract manufacturer and packager of prescription and over the counter pharmaceutical products. We are dedicated to providing comprehensive and innovative outsourcing services that exceed the uncompromising demands of the global pharmaceutical industry. 

 

An exciting opportunity exists to participate in the further development of operations that meet the highest customer and regulatory expectations. The successful individual will be eager to enhance their career and professional growth while contributing to the ongoing success of a fast paced expanding contract pharmaceutical manufacturer.

 

POSITION:                                  Lead Quality Specialist

 

SPECIFIC DUTIES:

  • Makes decisions on product quality. Approves and rejects batches. Performs final product release to the customer.
  • Supports resolution of any product quality issues with the customer.
  • Provides consultation within Focus Factory Cell on day to day issues that have potential to result in non-compliance and/or product non-conformance.
  • Supports Discrepancy Investigation Team in determining root cause and corrective actions.
  • Evaluates discrepancies and deviations to determine the effect on product quality and /or regulatory or customer requirements.  Approves Discrepancy Investigations and Planned Deviations.
  • Oversees completion of CAPA to ensure it is brought to closure in a timely manner.
  • Reviews and authorizes Master Documents such as Packaging Work Orders, Bulk Production Records, etc.
  • Reviews and approves APR’s, Customer Complaints, Protocols, Reports, Quality Improvement Sections, Change Control, component specifications.
  • Represents QA on project teams.
  • Oversees Consumer Complaint investigations.  Reviews and reports on any noted product quality trends.  If a significant trend is identified, convenes meeting to identify root cause and corrective action.
  • Oversees retain sample and archives programs.
  • Ensures Quality function coverage for gaps presented by vacations, volume fluctuation, etc.
  • Responsible for promoting and maintaining safe and healthy working conditions in his/her assigned work area; instructs, enforces and evaluates employees under their supervision to work in compliance with established safe work practices and procedures; ensures workers receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
  • Other duties as assigned.

QUALIFICATIONS:

  • B.A. /B.S. preferably in a scientific discipline, with a minimum of 5 years of pharmaceutical manufacturing experience.
  • A thorough understanding of Quality/Compliance as it relates to an FDA regulated environment.
  • Previous experience managing others.

 

CPL Niagara

100 Forest Ave.

Buffalo, NY  14213

Attn:  Human Resources Dept.

Fax to 887-7706

Or e-mail to hrniagara@cplltd.com

 

We thank all applicants in advance for their expression of interest; however, only candidates selected for an interview will be contacted.  No telephone or agency inquiries please.