We are actively seeking a Quality Control Chemistry Analyst to join our growing team. The QC Chemistry Analyst position supports the Quality Control group to maintain process optimization and manufacturing activities. The Analyst is charged with being a highly motivated member of the Quality Control (QC) Lab at the manufacturing facility, reporting to the QC Manager. Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in line with standards prescribed by USFDA. Maintain compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA. Perform IOQ/Calibration for instruments in QC lab with guidance of CQA. Execute and complete procedures and systems for RM, PM, FD and in process testing in QC lab.
Responsibilities include but are not limited to:
- Be cost effective and vigilant of laboratory reagents, glassware, etc. to ensure department is within the Revenue and Capex Budget as per spent analysis project.
- Provide feedback to management with laboratory standard hours for financial prudence in resource planning, allocation and manpower to ensure within approved budgets while building best in class quality processes and systems at site.
- Execute and maintain quality system controls to ensure no critical and major market complaints.
- Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency
- Perform day to day activities for the chemical laboratory which shall include testing of in-process, raw material, packaging material, finished product, and swab samples (as applicable).
- Ensuring compliance to systems and procedures in finished product section.
- Communicate with Supervisor and/or report any preparations or data that may result in an incidence and out-of-specification (OOS).
- Ensure that the QC Laboratory is in a ready state of compliance for internal and external audits.
- Maintain accurate and complete test records.
- Help maintain inventory by reporting needed supplies.
- Packaging and sending samples to contract laboratories.
- Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
- Maintain current knowledge of regulatory and industry standards, trends and advancements.
- Execute technology transfer of analytical methods for new products. Execute cleaning validation of new products.
- Assist in the monitoring of changes in the monographs Pharmacopoeia requirements, Regulatory agencies recommendations and implement the same in QC Lab.
- Apply CAPA for Lab failures in OOS.
- Prepare in timely fashion updating and revision of SOP, specification, STP and any other document.
- Assists in equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
- Establishes good working relation with contract laboratories.
- Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.
- Prepare in timely fashion updating and revision of SOP, specification, STP and any other documents.
- Assist in timely completion of Tech Transfer of Finished products.
- Ensure training of QC staff.
- Ensure that all equipment is calibrated.
- Perform the Training Tracking Tool/Software for Quality Assurance and Quality Control.
- Bachelor’s degree in Chemistry, or closely related scientific discipline.
- Degree in Chemistry is highly preferred.
- Minimum three (3) years in the field of Pharmaceutical (manufacturing facility).
- Background in the functional areas of Quality Control in stability, finished product and raw material testing.
- Basic understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
- Demonstrated knowledge in general laboratory equipment including but not limited to: HPLC, GC, UV-Vis and FTIR.
Knowledge & Skills:
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Excellent verbal and written communication.
- Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
- Knowledge of LIMS (Laboratory Information Management System) is a plus.
- Knowledge of cGMP, Regulatory guidelines, Compendial testing (USP), Internal auditing.
- Skills in coordination of calibration and preventative maintenance services, including but not limited to: setting up vendor contracts, processing quotes, generating purchasing orders and handling vendor invoices.
- Technical writing skills to generate SOPs and serve as the Subject Matter Expert.
- Support the Management to organize and maintain the QC team, good communications skills, front runner, and GMP trainer.
- Must have worked in Regulatory environment.
- Will be an added advantage if the individual has dealt with multiple audits personally.