Description:
The QC Analyst is responsible for conduction raw material, in process, finished product, and stability testing according to relevant SOPs and in adherence to the site production schedule and for accurately completing all documentation that supports testing procedures. The QC Analyst identifies issues related to laboratory testing and equipment that requires an in-depth knowledge of scientific methods and techniques. The QC Analyst is responsible for the safe, compliant, and efficient execution of job duties in a team environment. This position reports to the QC Supervisor.
Role Responsibilities:
- Conduct chemical and physical laboratory tests and analyze excipients, cleaning samples, raw materials, intermediates, and final products including protocol testing in a timely manner to ensure compliance with standards and production targets.
- Conduct verification of testing records and all associated electronic and hardcopy documentation.
- Compile datapacks along with generation of Final CoA as necessary.
- Receiving of samples into the QC Laboratory through LIMS.
- Recognize and report to immediate supervisor any issues or deviations from accepted standards.
- Provide status updates on own activities and productivity challenges according to defined procedures.
- Maintain data integrity and ensure compliance with FDA, GLP, QSR and cGMP regulations, as well as with company SOPs and specifications.
- Complete and conform to all training requirements for job role, including company-required and job role-specific training.
- Carry out and assist in the ongoing training of new and existing personnel, as appropriate.
- Author documents that ensure cGMP compliance, such as laboratory investigation, deviations, change controls, change notices, analytical test methods; analytical test method development reports; method validation protocols; method transfer protocols and reports; method verifications protocols and reports; and instrumentation qualification documentation (URS/IQ/OQ/PQ).
- Seek process innovation and continuous process improvement and perform quality improvement initiatives in the laboratory to meet site production goals.
- Observe all safety and compliance procedures and actively highlighting any safety concerns to help drive the reduction of accidents or near misses.
- Conforming to the safety culture on site on Zero, Believe it, Achieve it.
- Participate in the 6S activities within the QC Laboratory.
- Positively contribute to departmental goals and programs such as Right First Time
Qualifications
- Desired minimum 2 years analytical experience in the pharmaceutical industry
- 3rd level qualification in a relevant Science discipline
- Experience in pharmaceutical manufacturing facility.
- Demonstrate knowledge of cGMP requirements and practices including knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
- Proven track record in an analytical role. Must be proficient in common analytical instrumentation e.g. HPLC, Dissolution, GC, FTIR, Electro Chemistry (DME), UV/Vis and other USP instrumental and Wet chemistry technologies used in pharmaceutical Quality Control Laboratory.
- Demonstrate strong analytical laboratory skills and laboratory troubleshooting abilities.