Specialist, Metrology and Validation
MSD Malaysia, Rahway, NJ, United States
* Partner with scientific teams across DSCS to drive compliance and operational excellence* Onboard, qualify, and maintain laboratory equipment and instrumentation in both GMP and non-GMP environment* Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software packages in compliance with 21CFR11 compliance requirements.* Prepare, review, and approve documentation such as master inventory lists, qualification documentation, calibration documentation, computer system inventories* Support internal and external quality audits and maintain laboratory state of permanent inspection readiness* Prepare, review, and approve documentation such as master inventory lists, qualification documentation, calibration documentation, computer system inventories* Originate and own Investigations and Change Management records* Collaborate with cross-functional teams to deliver department level priorities
and initiatives.* A strong team player with the ability to work both independently and cross-functionally to deliver on complex objectives* Proven track record of strong technical and innovative problem solving* Desire and ability to learn new concepts outside of core expertise and training* Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills* Related industry experience with metrology and equipment maintenance and calibration.* Experience working within a GMP environment.* Understanding of GMP policies and procedures.* Demonstrated commitment to diversity and inclusion* Experience leading a team for a common goal* Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation management.* Experience supporting internal and external quality audits.* Experience in Instrument commissioning, qualification, and validation (CQV)* Experience in instrument computer system validation* Experience with IT, computerized systems, software and applications, including Secure Desktop* Experience with developing tools (e.g., Power Apps) or utilizing AI.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
#J-18808-Ljbffr
and initiatives.* A strong team player with the ability to work both independently and cross-functionally to deliver on complex objectives* Proven track record of strong technical and innovative problem solving* Desire and ability to learn new concepts outside of core expertise and training* Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills* Related industry experience with metrology and equipment maintenance and calibration.* Experience working within a GMP environment.* Understanding of GMP policies and procedures.* Demonstrated commitment to diversity and inclusion* Experience leading a team for a common goal* Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation management.* Experience supporting internal and external quality audits.* Experience in Instrument commissioning, qualification, and validation (CQV)* Experience in instrument computer system validation* Experience with IT, computerized systems, software and applications, including Secure Desktop* Experience with developing tools (e.g., Power Apps) or utilizing AI.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
#J-18808-Ljbffr