Specialist, Quality Systems & Compliance

MSD•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

The Global Quality Large Molecule Analytical Science (GQLMAS) department of our company's Manufacturing Division is seeking applicants for a specialist to support metrology and validation team at the West Point and North Wales, PA facility. The Analytical Metrology & Validation specialist will work as part of the Global Quality Large Molecule Analytical Science and drive a culture of quality and operational excellence across the GQLMAS West Point and North Wales labs. This role required working with a team of metrology and equipment coordination supporting the maintenance and qualification of analytical equipment and instrumentation within the GMP and non-GMP environment. The key responsibilities of this role will include: Manage equipment assets at multiple locations Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions Participate in computer system validation activities associated with new or upgraded equipment or software packages. Originate and progress Deviations and Change Control records Perform and document investigations and assist in developing and implementing CAPA plans Contribute to new SOP drafting, implementation, and revisions. Represent the laboratory on all aspects of laboratory equipment during audits. Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures. Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization. Willingness and ability to quickly upskill in our Facilities/Instrument support programs SAP, ProCal, BAS, LAMP, Electronic Validation, and other document and/or asset repositories Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment. Calibration Focus: Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation. Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships. Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support. Support the purchase, installation, and equipment qualification of new laboratory equipment. Validation Focus: Support primarily the qualification/validation of computerized analytical systems as per current guidelines. Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers. Perform any required change control during the life cycle of a computerized system. Decommission systems as required as part of the equipment qualification/validation life cycle. Manage the capital purchasing and initial installation of computerized analytical systems prior to validation. Participate in various data integrity and lab modernization activities as required. Will possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus). Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.

Requirements

HS Diploma/GED with working experience
Bachelor’s degree in biological or chemical science
Perform and direct team validation activities as an independent author
Highly skilled in operating analytical computerized instrumentation within a pharmaceutical or equivalent laboratory.
Collaborate independently with various project teams and execute tasks efficiently
Financial acumen- budgeting and forecasting experience required, managing a project's financial aspects including its cost, revenue, and profit.
Project management skillset, PMP certification is strongly preferred
Analytical Instrumentation
Analytical Instrumentation
Aseptic Manufacturing
Auditing
Batch Record Review
Communication
Computer Technical Support
Consulting
Corrective Action Management
Data Analysis
Decommissioning
FDA Compliance
Financial Management
GLP Regulations
GMP Compliance
Good Manufacturing Practices (GMP)
GxP Validation
Information Technology (IT) Support
Laboratory Sciences
Manufacturing Compliance
Personal Initiative
Policy Development
Quality Control (QC)
Quality Improvement Programs
Quality Standards

Nice To Haves

4+ years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification,

Responsibilities

Manage equipment assets at multiple locations
Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions
Participate in computer system validation activities associated with new or upgraded equipment or software packages.
Originate and progress Deviations and Change Control records
Perform and document investigations and assist in developing and implementing CAPA plans
Contribute to new SOP drafting, implementation, and revisions.
Represent the laboratory on all aspects of laboratory equipment during audits.
Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures.
Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.
Willingness and ability to quickly upskill in our Facilities/Instrument support programs SAP, ProCal, BAS, LAMP, Electronic Validation, and other document and/or asset repositories
Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment.
Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation.
Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships.
Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support.
Support the purchase, installation, and equipment qualification of new laboratory equipment.
Support primarily the qualification/validation of computerized analytical systems as per current guidelines.
Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers.
Perform any required change control during the life cycle of a computerized system.
Decommission systems as required as part of the equipment qualification/validation life cycle.
Manage the capital purchasing and initial installation of computerized analytical systems prior to validation.
Participate in various data integrity and lab modernization activities as required.
Will possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus).
Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.