Quality Control Analyst III

We are are seeking two skilled QC Analyst III Contractors to support the expansion of our GMP Quality Control laboratories—either in Chemistry or Microbiology. The ideal candidate will have at least 4 years of hands-on experience in a GMP QC lab environment. This role plays a vital part in routine and non-routine testing to support development through commercialization efforts.

Responsibilities:

• Perform routine and non-routine analytical or microbiological testing on raw materials, in-process samples, final product, and stability samples.
• Support weekend laboratory operations in either QC Chemistry or QC Microbiology labs.
• Ensure timely completion of testing assignments while adhering to cGMP guidelines.
• Participate in method transfers, qualifications, validations, and analytical method implementation.
• Maintain accurate records and perform peer data review; support data trending and investigations.
• Execute role-specific responsibilities such as SAP transactions, environmental monitoring, or equipment qualification.
• Assist with laboratory operations including reagent prep, inventory management, and equipment maintenance.
• Support document control by revising SOPs, work instructions, and testing protocols.
• Participate in audit/inspection readiness and assist in regulatory submissions as needed.
• Collaborate with cross-functional departments including Manufacturing, QA, and CMC Development.

Additional Information:

• Candidates must have recent hands-on GMP QC lab experience—data reviewers or research-focused backgrounds will not be prioritized.
• Candidates with over 10 years of QC experience may be considered overqualified unless aligned with the scope of the role.
• Training will begin on a Monday–Friday schedule before transitioning to the Fri–Mon weekend shift.
• Interview Process: Initial Zoom interview with hiring manager, followed by a panel with supervisor and current analyst.

Requirements

• Education: B.S. in Chemistry, Biology, Biochemistry, or related field. Associate degree considered with strong GMP experience.
• Experience:
• Minimum 4 years in a GMP QC laboratory (required).
• Experience in HPLC/UPLC testing using Empower (for Chemistry candidates).
• Experience with Bioburden, Endotoxin, Conductivity, and TOC testing (for Microbiology candidates).
• Familiarity with method transfer and lifecycle management preferred.
• Strong technical writing and investigation skills.
• Excellent organizational, communication, and collaboration abilities.
• Proficiency with LabWare LIMS, Excel, Word, and PowerPoint preferred.

Benefits

• Weekend shift
• Week shift
• 6-months contract with possible extension