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
- 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
- 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: $53.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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