Quality Control Analyst III (Mansfield,

Title: Analyst III, Quality Control Operations, LEQ

Overview:
The Quality Control Operations (QCO) LEQ Analyst III plays a key role in maintaining high standards of quality and compliance from development through commercialization. This position supports and executes laboratory equipment qualification activities in accordance with USP and applicable regulatory requirements. The role ensures laboratory instruments are fit for intended use throughout their lifecycle and supports data integrity, compliance, and continuous improvement within the laboratory quality system. This position is primarily onsite, with occasional responsibilities at a secondary location.

Key Responsibilities:

Perform and support laboratory equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with USP
Classify laboratory instruments (Groups A, B, and C) and determine appropriate qualification strategies
Review and approve qualification protocols, test scripts, and reports
Support equipment lifecycle management, including calibration, maintenance, requalification, and change control
Review vendor documentation (URS, manuals, certificates) to support qualification and compliance
Investigate and document deviations, discrepancies, and out-of-tolerance events related to equipment performance
Ensure qualification activities comply with SOPs, cGMP, data integrity principles, and regulatory expectations (FDA, EMA)
Collaborate with laboratory staff, quality, validation, facilities, and vendors to resolve equipment-related issues
Maintain accurate and complete documentation in electronic quality systems
Support audits and inspections by providing qualification documentation and technical explanations as needed
Adhere to internal standards, policies, SOPs, and industry regulations (GMP, GLP, ICH)
Participate in continuous improvement initiatives to enhance laboratory processes and efficiency

Qualifications:

BS in Chemistry, Biology, Biochemistry, or related scientific field
6 to 10 years of experience in a GMP Quality Control or similar regulated environment
Hands-on experience with laboratory equipment qualification
Strong knowledge of USP and instrument lifecycle management
Familiarity with cGMP, GLP, and data integrity requirements
Experience with laboratory instruments such as HPLC, GC, balances, dissolution, UV/Vis, pH meters, spectrometers
Ability to write clear, compliant technical documentation
Strong organizational and multitasking skills
Excellent communication and collaboration abilities

Nice to Have:

Experience in pharmaceutical, biotech, or contract testing environments
Exposure to computerized systems validation (CSV)
Familiarity with calibration and maintenance programs
Experience supporting regulatory inspections or internal audits

Estimated Min Rate: $37.10
Estimated Max Rate:... For full info follow application link.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.