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Quality Control, Senior Scientist | Quality Control, Scientist in Quality Assurance Job at Glenmar1

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Quality Control, Senior Scientist

Location:
Monroe, NC
Description:

Job details Job summary: Glenmark is actively seeking a Quality Control, Senior Scientist to join the growing team in Monroe, NC. The QC Senior Scientist position supports the Quality Control group to maintain process optimization and manufacturing activities. The Senior Scientist is a highly motivated member of the Quality Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager. Key responsibilities for this position will be: leading laboratory investigations, coordinating and review of chemistry testing as well as performing QC analysis in compliance to c GMP in line with standards prescribed by USFDA. Maintain compliance to data integrity and c GMP 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 info, 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. Responsibilities will include but are not limited to: Be cost effective and vigilant of laboratory reagents, glassware, etcetera 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. erform 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. Data review and trending to ensure integrity and adherence to standard operating procedures and c GMPs. 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 working understanding 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. Coordinates and processes departmental change controls. 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). Coordinates and performs laboratory investigations. 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. Education: Bachelor’s degree in Chemistry, or closely related scientific discipline. Degree in Chemistry is highly preferred. Experience: 10+ years in the field of chemical (manufacturing facility). Experience in the functional areas of Quality Control in stability, finished product and raw material testing. Basic understanding of c GMPs, c GLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines. 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 unaided with minimum supervision and use good judgment, or as a contributing member of a team. Ability to analyze info and perform structured decision-making on a daily basis. Ability to analyze information and perform structured decision-making on a daily basis. Strong organizational, analytical, troubleshooting and problem-solving skills. Ability to analyze info and perform structured decision-making on a daily basis. Good verbal and written correspondence. 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 Info Management System) is a plus. Knowledge of c GMP, Regulatory guidelines, Compendial testing (USP), Internal auditing. Technical writing ability to generate SOPs and serve as the Subject Matter Expert. 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 written communicationability to generate SOPs and serve as the Subject Matter Expert. Leadership/Managerial Attributes Support the Management to organize and maintain the QC team, good communications skills, front runner, and GMP trainer. Other Requirements (licenses, certifications, specialized training): Must have worked in Regulatory environment. Will be an added advantage if the individual has dealt with multiple audits personally. Equal Opportunity Employer– minorities/females/veterans/individuals with disabilities/niceual orientation/gender identity
Company:
Glenmark Pharmaceuticals
October 27 2019 on ListedBuy
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More About this Listing: Quality Control, Senior Scientist
Quality Control, Senior Scientist is a Quality Assurance Quality Control, Scientist Job at Glenmark Pharmaceuticals located in Monroe NC. Find other listings like Quality Control, Senior Scientist by searching Oodle for Quality Assurance Quality Control, Scientist Jobs.