Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
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 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, 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.
Requirements:
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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