QC Analyst (Microbiology)

Job Title: QC Analyst (Microbiology)

Location: Framingham, MA

2nd Shift, Wed-Sat, 12:00pm-10:30pm*

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.

Quality Control Microbiology (QCM) is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. Quality Control is also responsible for assisting in site wide studies and projects.

This position is responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs and relevant procedures for method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.

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

• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans

• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks

• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements

• Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified

• Performing the QC data review of executed tests by other analysts in a timely

• manner, ensuring adherence to the committed scheduled plans

• Informing his/her manager of any quality or HSE event (deviations, OOS,) in a timely manner to ensure investigation and impact assessment are performed appropriately • Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately

• Executing assigned CAPAs related to remediation plans, continuous improvements

• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately.

Key Involvement in Decision-Making Process

• Build remediation plans related to inspection readiness gaps, findings, deviations, …

Additional Accountabilities

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

About You

Basic Qualifications:

One of the following: 

• High School Diploma with minimum of 4 Years of relevant industry experience.
• Associates Degree with 2-4 Years of relevant industry experience.
• Bachelor’s Degree with 0-2 Years of relevant industry experience.
• Proficient with Microsoft Office tools such as: Word, Excel & PowerPoint.

Preferred Qualifications:

• 1 Year Experience in GMP lab environment.
• Proficiency in Microsoft Office tools such as: Word, Excel & PowerPoint.
• Experience with lab based data management systems.
• Experience in a Quality Control Laboratory.
• Experience with Environmental Monitoring, including Water Testing.

Special Working Conditions:

• Work in a laboratory with minimal use of chemicals.
• Ability to lift 10 lbs.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health a