Analyst 1, Laboratory Quality Control

About the position

Entry to developing individual contributor, who works under close supervision. Assists staff in various processes in the Quality Control function. Supports day-to-day laboratory activities such as sample management, supply ordering and receipt, and general housekeeping. Assists with analysis, qualification/validation activities, and lab investigations. Supports data review and metrics reporting. Executes continuous improvement projects with supervision. May execute testing under supervision.

Responsibilities

• Set up, operate, and clean laboratory equipment used to support production of intermediate, raw material, and finished products for API, medical device raw material components, and other products as directed; complete all associated support activities in the laboratory.
• Assure that QC laboratories run in a safe, clean, and environmentally sound manner.
• Review peer laboratory data to ensure accuracy and completeness.
• Demonstrate and develop experience on HPLC, UPLC, Karl Fischer, UV analysis, NIR, and other analytical techniques and train other laboratory personnel on these techniques.
• Develop skills to troubleshoot and perform minor maintenance, calibration, and repair of laboratory instrumentation.
• Provide input on investigations (OOS, OOT, invalid assays, and other lab-related non-conformances including investigations of audit observations) as needed.
• Support the implementation of relevant CAPAs and monitor effectiveness of CAPAs.
• Carry out duties in compliance with all state and federal regulations and guidelines including FDA, ISO, EPA, OSHA, and DEA, and adheres to all company and site policies and procedures.

Requirements

• High school diploma or two-year technical degree in a science or laboratory related field with four (4) years of Experience in a Quality Control (GMP regulated) Laboratory [Required]
• Bachelor's or Master's degree in Chemistry or related science degree (attained by August 2024) [Required]
• Experience applying mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlational techniques, sampling theory, and/or factor analysis is preferred
• Experience identifying and defining problems, collecting data, establishing facts, and making scientific-based conclusions is preferred
• Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and medical device is preferred
• Experience in Lab Operations and/or Quality processes/systems in a GMP Lab setting is preferred
• Experience working with Lab Systems or processes such as eLIMs, TrackWise, Non-conformances, and/or Change Control is preferred
• Familiarity with a variety of laboratory equipment, such as: GC, HPLC, UPLC, and/or Karl Fisher is preferred
• Requires ability and flexibility to work weekends and overtime (on a scheduled or emergency basis) to support shift operations.

Benefits

• Competitive pay based on experience, night shift differential, plus an annual performance bonus.
• Full medical, dental and vision coverage, competitive 401k, HSA/FSA, and company paid Pension plan.
• 120 hours paid vacation, plus 40 hours paid sick leave and an additional 40 hours paid personal leave.
• Tuition Reimbursement for eligible degree programs.