Pace Analytical

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QA Manager

QA Manager

ID 
2017-1793
# of Openings 
1
Job Locations 
US-MA-Woburn
Category 
Science

More information about this job

Overview

The Company:

Wolfe Laboratories, a subsidiary of Pace Analytical Life Sciences (PLS) and located in Woburn, MA, is a premier contract research organization that provides integrated early drug development solutions to the biopharmaceutical industry.  Wolfe Laboratories is an essential element of the drug development ecosystem, recognized by global and virtual biopharmaceutical companies as a science-driven organization whose mission is to provide outstanding discovery and development services tailored to its clients’ needs for rational formulation development.  

 

PLS is an industry leading contract lab supplying analytical chemistry and microbiology services to the Medical Device, Pharmaceutical, and Life Sciences industry.  Since our formation in 2006 we have grown at a rate of over 10% per year and established ourselves as one of the top ten contract laboratories within the United States providing cGMP services to a wide range of clients worldwide.  We attribute our rapid growth to our solid quality system combined with an exceptional culture of client service.

 

Summary:

We are actively seeking a candidate to manage our Quality Assurance (QA) systems team in Woburn, MA.  The ideal candidate is one who thrives working in a highly dynamic, team- oriented environment sharing the common goal of providing our clients with the information they need to improve the safety and effectiveness of materials produced and used in pharmaceutical, biologics and medical device products.

 

The QA Manager is directly responsible for management of all day-to-day QA administration and consulting support.  This includes all document control, GLP oversight, data package preparation, administrative tasks, document approvals, report approvals, performance of internal audits, data auditing, consulting with internal clients to provide guidance and direction, as well as other tasks identified in PLS SOPs. The Woburn QA Manager collaborates with the Oakdale, MN Senior Director of QA and staff on a routine basis to accomplish harmonization.  The ideal candidate is self-guided and highly motivated, demonstrating a strong sense of initiative, desire to collaborate with all departments and an interest in continuing to acquire new knowledge and skills. 

Responsibilities

  • Manage the Document Control system in Woburn with support from Oakdale, MN to include review of documents, approval of change requests and archive of documents
  • Provide QA Review and Approval of Excursion/non-conformances, deviations, OOT, OOS, and CAPA Reports. May need to author some records and investigations
  • Review and Approve Method Transfer, Validation and Project Requirements Protocols and Reports
  • Serve as Quality representative on all applicable client projects
  • Oversee all site GLP activities
  • Review and approve GLP Protocols and Reports
  • QA Consulting with Internal Clients
  • Manage training records
  • Conduct annual GLP and as applicable GMP training
  • Oversee Data Package Preparation Process
  • Data Review Supervision and Data Auditing
  • Perform Internal Audits and GLP phase inspection audits
  • Collaborate with Oakdale staff including remote meetings and internal audits
  • Assist with Review and Approval of Quality Agreements with Suppliers, Service Providers and Subcontractors
  • Review and Approve Supplier, Service Provider and Subcontractor Surveys
  • Assist with completion of Client Paper Audits
  • Host Client On-site Audits and prepare Responses
  • Review and Approve Equipment Records including basic laboratory equipment calibration, maintenance, and events such as storage units, balances, pipettes, and pH meters
  • Travel to the other PLS sites as well as subcontractors to conduct audits (approximately 1 trip per year)

Qualifications

  • Bachelor’s degree in chemistry, biology, or related field and a minimum 4 years’ experience in laboratory or manufacturing operations for pharmaceutical/biopharmaceutical or drug development organizations, or Master’s degree in science-related field and at a minimum 2 years’ experience
  • Knowledgeable of laboratory equipment and methods
  • Prior experience with quality systems related to GLP
  • Keen attention to detail and adherence to SOPs and Good Documentation Practices within a GLP or cGMP environment
  • Strong interpersonal skills
  • Exceptional verbal and written communication skills
  • Hands-on experience with editing documents in Microsoft Word and Excel
  • Ability to travel to Oakdale and subcontract laboratories

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