Senior Associate Metrology Investigator & Coordinator

Department: Engineering

Location: Monroe, NC

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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. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

POSITION SUMMARY:

The Sr. Associate Metrology Investigator & coordinator, at the direction of the Head of Department, is responsible for calibration monitoring, scheduling, tracking, handling, shipping, notifying, and other duties for BMRAM as assigned to ensure that the site calibrated instrumentation at the Glenmark Facility, remain in a state of compliance. As a member of Site Investigation Team (SIT) needs to investigate quality events and perform Root Cause Analysis (RCA).

Sr. Associate Metrology Investigator & Coordinator manage monthly schedule of upcoming calibration and provide to the instrument area owners every month. In addition to this, Work with the calibration technicians and the instrument owner to schedule routine instrument calibration.

To manage outside calibration through BMRAM and co-ordinate with vendor and instrument owner to complete the calibration activity on time.

JOB RESPONSIBILITIES:

BMRAM:

• Identifying all in-process test instruments, systems, tools, gages and scales used in the Glenmark Pharmaceuticals Inc. facility requiring periodic calibrations.

• Collaborates with the Instrument Owner to help with the initiation of on-boarding of new instruments or required changes.

• Maintain the instrumentation in the database, ensuring that the calibration instruments are within their calibration due date.

• Organize and maintain the calibration reports in a secure filling cabinet.

• Align BMRAM instrument database with new and existing active instrumentation to ensure schedules, and events has been properly created in the system.

• Executing on-demand calibration for troubleshooting, repair, and/or adjustment due to an unplanned calibration interval and documenting in BMRAM

• Initiating incidents and/or supporting documents and change controls, as appropriate.

• Approve calibration reports as needed based on request by Metrology Management.

• Create a report from the BMRAM system for monthly Quality Management Review.

• Work with HODs in initiating on-boarding new instruments into BMRAM.

  Investigation:

• Complete and maintain certified investigator training requirements to ensure SIT representation for identified area(s).

• Performing the investigation of quality events assigned using root cause analysis tools defined by company procedures, maintain timelines for closure of investigations assigned and to identify and initiate CAPA-s.

• Participate in continuous improvement initiatives for investigations and associated investigation certification process.

• Work with CIT team as needed for Major and Critical Investigations to align with corporate guidelines.

  Scheduling:

• Create monthly schedule of upcoming calibration and provide to the instrument area owners.

• Work with the calibration technicians and the instrument owner to schedule routine instrument calibration.

Quote, Shipping and Handling:

• Executing the calibration program, identify and schedule a qualified vendor to execute calibration work.

• Contact outside vendor for instrument quotations.

• Ship instrumentation off-site for external calibration activities.

• Handling the return instrumentation and provide the instruments back to the owning department

• Maintain tracking of all outgoing and incoming instruments.

Invoice Reconciliation in SAP:

• Monitor the aging report for Purchase Orders related to the instrumentation in SAP.

• Provide supporting documentation to closeout (GRN) Purchase orders in SAP.

• Maintain and reconcile discrepancies in invoicing.

General Administrative Support:

• Maintain upkeep of Breakroom equipment and supplies

• Process all incoming mail

• Maintain and order Company general office supplies

• Maintain Corporate Directory

• Point of contact for Business Card ordering

Education:

High School diploma or Associate Degree

Experience:

5-7 years of Computer based experience working in industrial setting.

Knowledge and Skills :

Basic to advance knowledge of Microsoft Office and Blue Mountain Regulatory Asset Manager (BMRAM).

Must be able to manage and support multiple priorities. Must be able to provide support to internal customers as well as maintaining vendor relationships.

BMRAM, SAP, MasterControl, Trackwise. Aspire application basic to advance knowledge

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