Position : Senior Quality Assurance Validation Specialist
Location : Woburn, MA (Onsite)
Length : 12 months
Job Description :
Our client is seeking a highly skilled Senior Quality Assurance Validation (QAV) Specialist to join their team. This position will provide crucial support to quality control laboratories, focusing on ensuring the quality and compliance of analytical instruments and lab systems.
Essential Duties and Responsibilities (but not limited to) :
Review and approve protocols, reports, validation issues, specifications, and assessments related to Analytical Instrument Qualifications (AIQ).Oversee periodic reviews for analytical instruments and lab systems.Review and approve data integrity assessments and audit trail reviews for lab systems.Approve BMRAM work orders for lab systems.Review and approve validation lifecycle documents (i.e., SLRA, DI Assessments, DR / DQ, IQ / OQ / PQ protocols / reports, and risk assessments).Represent QAV independently in cross-functional project meetings.Communicate quality decisions in support of qualification and validation activities in alignment with SOPs, quality standards, and industry regulations.Provide additional onsite support at the client’s manufacturing facility as needed.Provide weekly updates on hours used and remaining on the Purchase Order (PO).Qualifications :
Bachelor’s degree in Engineering, Microbiology, Chemistry, Biochemistry, or other related Science field.Experience in biopharmaceutical or biotechnology-based GMP operations, with a focus on quality and / or validation.Hands-on experience with analytical instrument qualifications, computer system validation, and data integrity programs.Strong understanding of FDA and EMA regulations.Ability to thrive in a fast-paced, dynamic environment, balancing individual and team responsibilities.Experience reviewing or authoring CMC sections of regulatory filings.Excellent communication skills, both oral and written, with a strong technical writing background.Strong organizational skills and meticulous attention to detail.Ability to approach problem-solving and decision-making with a data-driven mindset.Proven ability to manage complex projects and prioritize tasks effectively.Experience in driving continuous improvement efforts.POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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Job #17395
