Great opportunity to get your foot in the door with one of the top Cell Therapy companies in the Cambridge, MA area!!

**Must have GMP/Cleanroom experience**

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com

Description:

Department Description:

Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance.

Position Summary:

• Perform routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation.

DUTIES AND RESPONSIBILITIES:

• Perform microbiological assays for in-process and final product samples.
• Perform analytical methods for final bulk material/finished goods.
• Test and disposition of raw materials and perform environmental monitoring.
• Review of QC data for compliance to procedures and specifications.
• Calculate and evaluate results.
• Participate in lab maintenance and administration duties.
• Initiate lab investigations and deviations.
• Lab support including but not limited to glass washing, autoclaving, etc.
• Effectively demonstrate an understanding of CGMPs and how it applies to specific responsibilities.
• Follow accurate oral and written procedures for testing of in-process and final product samples.
• Provide input to the technical composition of operating documentation.
• Work independently under general supervision and direction.
• Work in compliance with cGMPs.
• Practice safe work habits and adheres to safety procedures and guidelines.
• Maintain lab documentation and notebooks, ensuring timely review, reconciliation and filing.
• Other duties as assigned

Preferred Skills:

• GMP, PCR, Sample testing, environmental monitoring, Quality control, microbiology, Qc, Biology, Cgmp

Additional Skills & Qualifications:

• Bachelor’s degree or equivalent education and experience. Biotechnology certification will also be considered.

Preferred Qualifications:

• 1 year of experience in a CGMP lab environment.
• Proficient in Outlook, MS Word, Excel and lab based data management systems.
• Experience with microbiological testing or environmental monitoring

Experience Level:

Entry Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.