CMC Quality Control Analyst

We are seeking a motivated Scientist to join our CMC Quality Control team supporting daily analytical testing. This role will focus on preparing buffers and media maintaining cell cultures managing lab inventory logging and shipping samples and performing analytical testing. The position collaborates closely with Technical Operations Quality Assurance and internal/external QC teams to support advancement of preclinical gene editing programs.

• Prepare buffers and media to support testing.
• Maintain cells perform cell culture and manage cell testing.
• Identify key consumables and supplies within the QC Lab and maintain stock as needed.
• Log incoming samples.
• Ship samples controls and reference standards to third-party organizations.
• Perform analytical testing of release and stability samples. 
• Maintain lab housekeeping program.

Qualifications :

Minimum Required Qualifications:

• B.S. in Chemistry Biology or a related field with 34 years of relevant experience.
• Proficiency in mammalian cell culture and cell-based functional assays (ELISA and dPCR required; NGS experience a plus).
• Experience with Good Documentation Practices and electronic lab notebooks (ELN).
• Ability to execute routine testing follow SOPs maintain accurate records and adhere to company policies.
• Strong attention to detail with the ability to critically analyze data and reports.
• Knowledge of GxP principles (hands-on GxP experience preferred).
• Proactive mindset with strong ownership and follow-through.
• Excellent time management and multitasking skills.
• Ability to work independently and collaboratively in a cross-functional environment.
• Effective written and verbal communication skills.

Preferred Qualifications:

• Experience with LIMS and data management systems.
• Experience authoring reviewing and approving documents in electronic document management systems.
• Working knowledge of ICH guidelines FDA/EMA regulations and cGMP documentation practices.
• Authorization to work in the United States without restriction or sponsorship.

Additional Information :

What to Expect in the Hiring Process: 

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader
• 30 Minute In-Person Onsite Meeting with the Team

Additional Details: 

The position is Full Time Monday-Friday 8am-5pm. Candidates currently living within a commutable distance of Boston MA are encouraged to apply.

Excellent full-time benefits include:

• Comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Annual rate is between $36.00-$40.00 depending on education and experience 

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time