QC Expert (Microbiology)

Job Title: QC Expert (Microbiology)

Location: Framingham, MA

Shift: Mon-Fri 830am- 5pm

About the Job:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Quality Control team is dedicated to the development and validation of

methodologies using state-of-the-art technology and responsible for ensuring that all production lots and materials meet the required quality standards, supporting regulatory compliance, and operational excellence of the organization

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Providing his/her analytical expertise for any project, troubleshooting, investigation on analytical methods and lab technologies
• Coordinate analytical testing on projects (validation/transfer), ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, and records related to these tasks. Recording all expected raw data, calculations, and information related to his/her tasks, to comply with cGMP and data integrity requirements
• Writing/reviewing protocols and reports related to analytical validation/transfers and qualification activities
• Writing/reviewing and maintaining accurate analytical methods and procedures
• Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively in any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Performing periodic trend analysis on method performance to determine the need to revalidate, optimize, or replace the method. Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately
• Supporting QC teams during internal and external audits and inspections

Key Roles:

• Analysis on technical issues and troubleshooting strategies (A)
• Identify priorities and propose a remediation plan on ALCM strategy (A)
• Propose remediation actions from findings and CAPAs related to analytical methods (A)

Additional Accountabilities:

• Ability to perform tasks in a Quality Control Laboratory environment and capable of lifting at least 10 pounds.
• May be required to enter controlled environments following proper gowning protocols.

About You:

Basic Qualifications:

• Bachelor's Degree in Life Sciences discipline and 9+ years' experience in a cGMP lab environment, or
• Master's Degree in Life Sciences discipline and 6+ years of experience in a cGMP lab environment.
• Experience in Analytical Method Development, Validation, and Transfer.
• Proven project management experience
• Technical expertise in several analytical platforms.
• Strong and effective written and verbal communication skills.
• Ability to present technical data and work independently on scientific projects.
• Familiarity with USP and global compendial regulations.
• Scientific technical writing ability, including authoring and revising SOPs, validation protocols, and technical reports.
• Experience in troubleshooting assay and equipment issues.
• Working knowledge of Aseptic practices and techniques.

Preferred Qualifications:

• Ability to perform laboratory work using chemicals as required
• Ability to occasionally lift up to 10 lbs.
• Occasional travel (< 10%) may be required to provide on-site support to Biologics QC laboratories for troubleshooting support.
• Occasional nights, weekends, and holidays may be required