Analyst II, QC Microbiology

Role Summary

We are seeking a strong candidate to perform routine testing in QC Laboratory following cGMP, including Environmental and Utilities Monitoring, and to support microbiology methods such as Environmental/Utility monitoring and Growth Promotion.

Responsibilities

• Perform routine QC testing in accordance with SOPs and cGMP guidelines. Some ability to troubleshoot. Some supervision required.
• Verify data to ensure accuracy.
• Assist with audit readiness of laboratory area and calibration and maintenance of routine laboratory equipment.
• Utilize a range of electronic systems such as ERP, QMS, LIMS, and equipment management software.
• May author and review SOP changes; may participate in change controls, CAPAs, etc.
• Resolve routine problems by utilizing appropriate resources. May support investigations.
• May participate in protocols for procedural validations and instrumentation qualifications.
• May work on special projects as needed. Contribute towards continuous improvement.
• Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
• Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.
• Work individually and as a team with quality and attention to detail. Good communication skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner.
• Demonstrate and adhere to Lantheus corporate Values. Actively demonstrate quality, accountability, customer service, efficiency, collaboration, and safety, as well as appropriate workplace behaviors and professionalism.

Qualifications

• Requires a BS and typically 2 years of related experience; an advanced degree and limited experience; or equivalent combination of education and work experience. Degree in a related scientific discipline (e.g., biology) and experience in the pharmaceutical industry, related GMP environment, or equivalent preferred.
• Site-based: This position is site-based in N. Billerica, requires flexibility and requires a full-time presence on site.

Other Requirements

• Essential personnel; flexibility with scheduling requirements: routinely scheduled work, and/or overtime work required on evenings, weekends, and/or holidays, including during adverse weather conditions. Some non-routine travel may be required.
• Able to pass eye exam for color and have correctable vision. Vision capable of particulate detection preferred.
• Must be able to lift/move materials up to 50 lbs.
• Work with, or in proximity to, potentially hazardous chemical, biological, and/or radioactive materials with proper training.
• Experience with LabVantage LIMS preferred.