Job Summary:

Glenmark is actively seeking a Quality Control Analyst to join the growing team in Monroe, NC. The QC Chemistry Analyst position supports the Quality Control group to maintain process optimization and manufacturing activities. 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 at Monroe with guidance of CQA. Execute and complete procedures and systems for RM, PM, FD and in process testing in QC lab. Provide information, data for evaluation and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during analytical TT and AMV performed in QC lab. Able to be a qualified trainer for QC related systems and SOP’s and responsible that personnel are appropriately trained.

Major Responsibilities

• Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency
• Performs operations necessary for quality testing and identifies compliance or deviations of quality procedures and test methods.
• Completes routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation.
• Conducts data review and preliminary evaluation of results.
• Solves problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc.
• Provides input to the technical composition of operating documentation.
• Work is closely supervised. Follows standard practices to obtain solutions. Contributes to the completion of routine technical tasks.
• Contacts are primarily with immediate supervisor and other personnel in the section or group
• Review of in-process testing and executed batch production record.
• Preparation, review and approval of sampling matrix and hold time schedule.
• Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS).
• Performs routine equipment maintenance.
• Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary.
• Gives laboratory/quality control disposition of raw material and finished product.
• Establishes good working relation with contract laboratories.
• Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols.
• Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.
• Conducts statistical evaluation of the manufacturing and inspection process and training QC staff.
• Assures laboratory databases are maintained and accurate.
• Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing
• Ensures that all equipment is calibrated

Qualifications

• Bachelors of Science degree in Chemistry, or closely related scientific discipline, required; Bachelor of Science Degree in Chemistry, preferred.
• 5 years of relevant pharmaceutical manufacturing experience required; 7 years of direct experience, preferred.
• Excellent knowledge of general laboratory instrumentation, such as HPLC, GC, UV, and FTIR and others.
• Good understanding of cGMP.
• Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Good documentation skills.
• Strong organizational skills.
• Time management skills.
• Good analytical and observation skills.
• Good knowledge of basic mathematical skills, including measurement.
• Able to multi-task.

Glenmark is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.