What are the responsibilities and job description for the Quality Control Analyst II position at Tap Growth ai?
Role: Quality Control Analyst II
Location: Norton, MA
Pay: $45/hr.
The Quality Control Operations (QCO) Analyst II Contractor supports maintaining high standards of quality and compliance from development through commercialization. The role includes performing routine and non-routine testing, participating in data trending, investigations, and lab operations, and supporting method transfers, qualification/validation, verification, and implementation. This position enhances QC efficiency and effectiveness.
Key Responsibilities:
- Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs
- Support weekend lab operations and maintain training records
- Assist in lab equipment and inventory maintenance, including reagent and sample prep
- Review data timely and qualify as a data reviewer
- Perform operational assignments (raw material processes, environmental monitoring, in-process testing)
- Contribute to updating controlled documents (SOPs, work instructions, test methods)
- Follow internal policies, SOPs, and regulatory standards (GMP, GLP, ICH)
- Participate in continuous improvement initiatives and cross-functional collaboration
- Support regulatory submissions, inspection readiness, and audits
Requirements:
- B.S. in chemistry, biology, biochemistry, or related field
- 4-8 years of pharmaceutical/biotech experience in GMP QC or equivalent
- Experience in method transfer/implementation; understanding of method lifecycle management preferred
- Strong technical writing, data analysis, problem-solving, and organizational skills
- Excellent communication and teamwork
- Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred
- Let me know if you have any queries.
Salary : $45