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