Randstad Lead Quality Analyst in North Billerica, Massachusetts
Lead Quality Analyst
location:North Billerica, MA
salary:$58,000 - $68,000 per year
date posted:Wednesday, February 13, 2019
Lead Quality Analyst
Provide lead support and technical expertise to the QC laboratory group as well as other divisions within the organization to ensure quality, compliance and efficiency in QC laboratory performance. Perform testing/review on incoming materials, finished products and stability studies in QC Laboratory. Oversee QC warehouse/incoming inspection activities.
QC warehouse SME lead: lead processes and improvements such as incoming inspection, dock to stock, material status, inventory management, and QC use of Enterprise Resource Planning (ERP).
Provide weekly lab schedule (unless managed by another designee), assure priorities are met, and communicate with key stakeholders.
Responsible for ordering and maintaining laboratory supplies and oversee calibration and maintenance of laboratory equipment (unless managed by another designee). May assist or write and execute protocols for procedural and instrumentation validations, and quality validation assessments (QVAs).
Perform non-routine/advanced lab testing in accordance with SOPs and cGMP guidelines. Perform routine QC testing as needed. Perform verification and approval of data to ensure accuracy.
Assist with audit readiness of laboratory area and act as SME during audits.
Utilize a range of electronic systems such as LIMS, document/equipment management software, and ERP.
Author, review and act as business owner for document changes; write/execute change controls, CAPAs, and utilize other quality systems.
Resolve routine, non-routine and advanced problems independently by utilizing appropriate resources. Provide problem solving and technical skills to support and/or lead the resolution and documentation of investigations.
Working hours: 7:30 AM - 4:30 PM
Maintain and increase personal technical, regulatory and compendial expertise, and contribute to team objectives. Extensive knowledge of industry practices for assigned area.
Extensive knowledge in specialized functions. A wide and comprehensive acquaintance with, and understanding of, both general and specific aspects of the job and their practical application to complex problems and situations ordinarily encountered. Demonstrates flexibility to handle changing priorities without impact to other projects. Minimal supervision required. Follows established procedures.
Team player who can work independently with quality and attention to detail. Strong communication skills both oral and written, professional conduct. Effectively and efficiently participate in assigned tasks in a quality manner. Solid interpersonal skills, ability to take a lead role and interact with a diverse group of individuals at various levels (including key-stake holders, inter-organizational and outside contacts such as vendors or CMO representatives). Represents the organization in providing solutions to difficult technical issues.
Actively promote safety rules and awareness. Reports and takes initiative to correct safety & environmental hazards. Work with potentially hazardous chemical, radiological and/or biological materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
May perform incoming material inspections using Acceptable Quality Level (AQL) standards, visual inspections (qualified operators), component and material verifications (functional and dimensional verifications), raw material sampling, stability setup/pulls, reserve (retain) and stability inventory, release and stability testing, and project support.
Requires 6 + years with a BS ( 3+ years with an MS) or equivalent combination of education and experience, and previous relevant experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous experience preferred.
Some non-routine travel may be required.
Flexibility with scheduling requirements-may include shifts, overtime, weekends and holiday coverage, including during adverse weather conditions.
Must be able to lift 50 lbs.
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