Quality Control Analyst - Metrology

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well.

Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.

Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.

POSITION SUMMARY:

The Calibration/Instrument Analyst initiates, coordinates, and administers the calibration program for the Monroe QC facility and conduct or coordinate the inspection, calibration, and repair of all instruments, equipment and systems used for the manufacture and measurement and determination of quality of pharmaceutical products in accordance with current industry regulations and practices in the U.S.A. and the state of North Carolina.

JOB RESPONSIBILITIES:

• Under the direction of the Quality Control (QC) Sr. Manager or Manager, the calibration/instrument Analyst will plan, schedule, conduct and record planned and unplanned inspection, troubleshooting, maintenance, and calibration of instruments, tools, equipment and laboratory and water systems in any area of the plant. This includes initiation and administration of the QC calibration program. Keep laboratory staff and management team of notified of calibration status of all instruments in the program. Independently identify, prevent and solve technical problems related to calibration of laboratory and manufacturing measuring instruments, equipment and systems.
• Independently identify, prevent and solve technical problems related to calibration of laboratory and manufacturing measuring instruments, equipment and systems. Track and maintain up to date the calibration status and records of all instruments, equipment, and tools.
• Troubleshoot automation and instrumentation problems for laboratory equipment.
• Organize and maintain the calibrations in Blue Mountain system.
• Independently identify, prevent and solve technical problems related to calibration of laboratory, measuring instruments, equipment and systems.
• Identify, tag out, and write calibration instructions, schedule and conduct all calibrations. Identify and initiate procurement of all tools, equipment, and calibration standards to be used for the maintenance, troubleshooting, and calibration program. Conduct general maintenance, repairs and upgrades or replacements to facility instruments and scales.
• Identify, communicate and cooperate or guide internal and third party calibration services providers and provide technical support during process maintenance and services to the facility and its equipment. Will inspect, maintain, and maintain above systems in accordance with current ASTM standards, FDA guidance, internal SOP’s and industry practice. Review all calibration certificates from third party services to ensure compliance with our procedures.
• Conduct timely planned preventive maintenance and unplanned repairs and calibration completing documentation as required by local SOP’s.
• Support other QC Analysts to conduct their work. Support maintenance and troubleshooting of electrical and PLC controlled equipment.
• Participate in equipment user requirement specification discussions.
• Manage stability chambers, including daily monitoring and excursion evaluation.
• Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
• Maintain knowledge of current regulatory requirements and standards as they pertain to the Stability and Quality Control departments.
• Represent Glenmark as appropriate in FDA, notified body, internal and other regulatory audits.
• Work in close collaboration and support with other members of the CMC team responsible for drug product development and support to management, as necessary
• Domestic and international travel up to 5% may be required to accompany technical staff in the factory acceptance and inspection of laboratory equipment.
• Evaluate and continuously improve Software systems/procedures, quality and compliance with regulatory requirements, best practices and quality systems procedures.
• Be proactive with regulatory and industry changes.

Education :

A minimum of a Bachelor’s degree in Science is required.

Experience:

A minimum of 2 years or more of experience in a Pharmaceutical Quality Control Laboratory environment, including experience with calibrations / qualifications along with involvement with regulatory audits

Knowledge and Skills :

• Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), cUSP and ICH Q1A (R2).
• Experience with electronic systems such as Blue-Mountain, Trackwise, SAP and/or other relevant QMS systems are required
• Experience required with sophisticated Laboratory Equipment such as UPLC, HPLC, GC but not limited to.
• Experience with Laboratory Equipment Software such as Empower but not limited to,
• Strong documentation skills are required, including writing SOPs, technical papers and investigations.
• Proficiency with Microsoft Word, Microsoft Excel and Power Point are required.
• Strong organizational and communicative skills are imperative.
• Ability to lift 30 lbs and work within different extreme temperature/humidity environments as encountered in the various stability conditions.