Analyst II QC Lab

About the role

Performs advanced quality control testing and laboratory support activities to ensure product quality and compliance with regulatory requirements. Executes complex microbiological or chemical testing; supports investigations, method qualifications and validations, equipment calibration activities, data review, and laboratory continuous improvement initiatives. Provides technical guidance to QC Analyst I personnel and helps maintain inspection readiness in accordance with cGMP, GLP, SOP, and data integrity requirements. Supports laboratory investigations, NCR/CAPA activities, sample shipments to third-party laboratories, and coordination with external service providers.

Responsibilities

• Perform advanced microbiological testing using approved methods and procedures.
• Execute and review environmental monitoring, water testing, bioburden, endotoxin, and other microbiological analyses.
• Support environmental monitoring investigations and assessment of microbiological excursions.
• Trend microbiology data and identify adverse trends, recurring issues, and opportunities for improvement.
• Support microbiological method qualifications, verifications, validations, and transfers.
• Perform and support equipment calibration, maintenance, qualification, and troubleshooting activities.
• Review laboratory data, test records, and reports for accuracy, completeness, and compliance.
• Assist with laboratory investigations, deviations, NCRs, CAPAs, and change control activities.
• Support internal audits, customer audits, and regulatory inspections.
• Mentor and train Analyst I personnel on laboratory procedures, testing techniques, and documentation practices.
• Support procurement of laboratory supplies, media, reagents, and consumables required for testing activities.
• Coordinate with external vendors for equipment calibration, troubleshooting, maintenance, and contract testing services.
• Prepare, package, and ship samples to third-party laboratories while maintaining proper documentation and chain of custody.
• Ensure compliance with SOPs, cGMP, GLP, safety requirements, and data integrity principles.
• Perform advanced chemical and physical testing of raw materials, in-process samples, and finished products using established analytical methods.
• Complete complex analytical techniques and provide technical support for routine laboratory operations.
• Troubleshoot analytical methods, instrumentation, and laboratory processes to ensure reliable and accurate results.
• Support Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, nonconformance, and laboratory investigations.
• Assist with analytical method qualifications, validations, verifications, and transfers.
• Review analytical data, calculations, chromatograms, and laboratory documentation for accuracy and compliance.
• Support laboratory projects, process improvements, and continuous improvement initiatives.
• Provide technical guidance and mentorship to Analyst I personnel.
• Support NCRs, CAPAs, and quality system activities related to laboratory operations.

Requirements

• 2-5 years of experience in a regulated laboratory environment.
• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or a related scientific field.
• Working knowledge of cGMP, GLP, data integrity, and Good Documentation Practices (GDP).
• Experience supporting investigations, method validations, and equipment qualification activities preferred.
• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to review technical data, identify trends, and work independently with minimal supervision.
• Proficiency with laboratory software, LIMS, and Microsoft Office applications.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Pay

The estimated base salary for this position is $72,000 - $99,000 annually. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• Medical and dental coverage starting on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident.
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence, and paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.