Quality Control Analyst

About the role

Purpose

Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system.

Responsibilities

• Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods.
• Performs, coordinates and supports method validations and prepares final reports documenting the validation findings.
• Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing.
• Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action.
• Reviews and approves all laboratory testing documentation. Responsible for the preparation of Test Failure Investigation reports.
• Performs and coordinates microbiology testing release with the Final Quality Control Records maintained in SAP and LIMS.
• Responsible for leading others indirectly.
• Prepares trend and metric laboratory reports in conjunction with the Microbiology Manager.
• Must make sure that all laboratory supplies, inventory and on-going lab operations do not exceed a specified budget. Ensures that the correct and most updated versions of SOP's are available to all laboratory personnel
• Reviews current regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues.

Qualifications & Requirements

• Bachelor's Degree in Microbiology or related Biological Sciences, with a minimum of three (3) years of lab experience.
• Two (2) years of experience in Industrial Microbiology with an emphasis in the Pharmaceutical and/or Medical Device industry, or equivalent experience. Knowledge of microbiology and regulatory requirements preferred.
• Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred
• Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.
• Experience working in a GMP regulated environment preferred. Audit experience preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.