QC Analyst

Accentuate Staffing is partnering with a leading pharmaceutical manufacturing company that is hiring for a QC Analyst. This is a contract-to-hire opportunity offering competitive pay and the opportunity to work in a regulated GMP laboratory environment. The ideal candidate has strong wet chemistry experience, hands-on analytical testing in an FDA-regulated setting, and the ability to support investigations and cross-functional manufacturing operations.

Multiple shifts available

• 1 st shift: (1) Monday to Friday 6am to 2:30pm & (1) Monday to Friday 9am to 5:30pm

• 2 nd shift: Monday to Friday 3pm to 11:30pm

Responsibilities:

1. Perform analytical and wet chemistry testing in accordance with approved SOPs and regulatory requirements.
2. Conduct routine and non-routine testing of raw materials, in-process samples, and finished products.
3. Record, analyze, and report test results; identify and escalate atypical or out-of-specification (OOS) results.
4. Review and revise laboratory procedures, testing methods, and documentation as needed.
5. Support internal audits and maintain inspection-ready laboratory status.
6. Assist with instrument qualifications, method validations, and process validations.
7. Collaborate with formulation, filling, and packaging teams to support manufacturing operations.
8. Train junior analysts on laboratory techniques, SOPs, and compliance standards.
9. Participate in investigations and assist with corrective and preventive actions (CAPA) as needed.

Requirements:

1. Bachelor’s degree in Chemistry (preferred) or related science with coursework in General, Organic, and Analytical Chemistry.
2. 2–3+ years of analytical chemistry experience in an FDA-regulated pharmaceutical manufacturing environment.
3. Strong hands-on experience with wet chemistry techniques and laboratory instrumentation.
4. Working knowledge of cGMPs, GLPs, and FDA regulations.
5. Experience reviewing laboratory documentation and supporting regulatory audits.
6. Ability to manage multiple priorities in a fast-paced manufacturing laboratory.

• Ensuring that quality business analysis standards
• Perform quality assurance reviews of existing documentation
• Perform quality assurance review of distribution records
• Apply quality assurance monitoring standards, processes and procedures
• Assist in quality assurance development projects and supplier evaluations
• Manage portfolio of reporting solutions including ongoing testing and quality assurance
• Participate in the execution testing and quality assurance related activities
• Ensure data and reporting quality
• Ensure quality of customer data
• Perform quality assurance review and disposition of returned tissue/product
• Perform ad hoc analysis on various business issues
• Resolve internal and external quality assurance/assessment problems or questions
• Maintain integrity of web analytics through ongoing data monitoring and quality assurance testing of tracking solutions
• Review all business analysis of various business segments
• Provide technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards
• Work with the quality assurance staff to develop testing criteria and scenarios
• Perform analysis of business processes and data that pertain to business issues
• Conducting quality assurance reviews of categorization provided by outsourced providers
• Provide quality assurance for general medical and specialty examination reports
• Solving analytical business problems using data