Quality Control Analyst III

We are are seeking two skilled QC Analyst III Contractors to support the expansion of our GMP Quality Control laboratorieseither 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.

• 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 MondayFriday schedule before transitioning to the FriMon 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