Quality Assurance Specialist II

Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We share a common goal to bring real value to people, healthcare professionals, and health businesses worldwide. Driven by our commitment to improving our health, we deliver services that offer hope – and a better, safer, and healthier life for everyone.
 
This is an onsite, full-time, Monday through Friday from 8:00 a.m. to 5:00 p.m. position supporting the Woburn, MA location. 

Summary:

We are actively seeking a candidate to support 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 Specialist is directly responsible for overseeing day-to-day QA administration and consulting support. This includes all document control, GLP oversight, data package preparation, administrative tasks, document approvals, report approvals, the 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 Specialist will collaborate with the Salem, NH, QA Director and staff on a routine basis to accomplish harmonization. Additional tasks include supplier survey approval, client audit hosting, response preparation and QA report authoring, and equipment group support. The ideal candidate is self-guided and highly motivated, demonstrating a strong sense of initiative, a desire to collaborate with all departments, and an interest in continuing to acquire new knowledge and skills. 

Job Responsibilities:

Provide support to all areas of the PLS operation.

• 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. 
  1. Conduct annual GLP training.
• Oversee Data Package Preparation Process
• Data Review Supervision and Data Auditing 
• Perform Internal Audits and phase audits.
• Assist with the completion of Client Paper Audits
• Host On-site Client 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. 
• Other tasks as assigned by the supervisor.

Requirements:

• Bachelor’s degree in chemistry, biology, or related field and a minimum of 1 (one) year experience in laboratory or manufacturing operations for pharmaceutical/biopharmaceutical or drug development organizations, or Master’s degree in a science-related field and at a minimum 5 (five) years experience.
• Knowledgeable of laboratory equipment and methods.
• Prior experience with quality systems related to GLP.
• Familiarity with FDA, cGMPs, GLPs, and a thorough understanding of Good Documentation Practices
• Strong attention to detail, adherence to SOPs, and Good Documentation Practices 
• Strong interpersonal skills
• Exceptional verbal and written communication skills
• Hands-on experience with editing documents in Microsoft Word and Excel.
• Ability to excel in a fast-paced work environment.
• Ability to multi-task and be flexible with changing priorities.

Physical/Mental Requirements:

The physical demands described herein represent those that must be met by an employee to successfully perform the job's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

Working Environment: 

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gasses, noxious odors, and related items in a lab setting.

OFCCP Statement:

Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veteran, individuals with disabilities, sexual orientation, or gender identity.

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