Requisition ID: QUA009076
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Understands the fundamental business drivers for the company and uses this knowledge in own work and is proficient in multiple functional areas of the laboratory. Ability to interpret Company Quality Policies and Guidelines for daily application. Understands and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace. Possesses an expanded knowledge of theories, processes and procedures in the Quality Laboratory, including the knowledge and understanding of pharmaceutical Equipment Qualification, Calibration, Preventive Maintenance, Corrective Maintenance regulatory requirements and Company SDLC procedures. Possesses strong technical writing capabilities and is able to compile more complex investigations, procedures, justifications, qualifications/validation protocols, etc. Ability to independently respond to advance requests for Lab Instrument problems and failures and provides trending of data and proactively utilizes trending of data to improve the operation or drive changes. Develops presentations which includes those needed to influence the actions and decisions of others and presents to own work team or large groups with limited assistance of others. Accountable for technical contribution to work or project team and may lead or manage a small project team.
Primary activities include, but are not limited to:
- Works with PM mechanicals and or vendors to ensure Equipment Qualification and Calibration on time of schedule, protocols and process.
- Supports and leads continuous improvement projects with minimal assistance and works to ensure sustainability of implemented changes identified through lean six sigma tools/activities.
- Leads Tier I Activities and coordinates daily activities to ensure daily assignments and long-term activations are completed and on-track of schedules or possible obstacles.
- Demonstrates in-depth understanding of equipment performance and usage methodology. Able to train lab chemists and teammates as a SME.
- Promotes an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example.
- Leads root cause analysis and corrective action identification for deviation occurrences and properly documents investigations. Identifies proactive measures to ensure right first-time achievement.
- Support remediation of monthly walk thru audits observations and works to ensure compliant operation of the laboratory to ensure successful outcomes of audits.
- Works cross functionally to ensure proper prioritization/effective utilization of laboratory equipment.
- Interprets and apply compendial and internal monographs, NDAs, CFR and Company Analytical Standards, if applicable.
- Provides technical and analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD).
- Identifies improvement opportunities and both independently and as a facilitator of change, implements improvements. Learns a variety of tools to drive continuous improvement (lean six sigma, human error prevention, etc.).
- Maintains 5S organization throughout the laboratory and leads 5S activities to ensure compliance.
- Understand and apply Data Integrity concepts in depth within Company Data Integrity Center of Excellence.
Education Minimum Requirement:
Bachelor's degree in Science, Chemistry Biochemistry, Biology or related chemistry science field
Required Experience and Skills:
- A minimum of 2 years of experience in Laboratory GMP Equipment Qualification in a regulated environment.
- Experience in pharmaceutical manufacturing and cGMP environment.
- Experience in SDLC.
- Experience authoring technical documentation within a cGMP context.
- Proven technical communication (written & presentation) skills
- Experience in FTIR, HPLC, UV/VIS, NIR, and their software.
- Experience in Change Control and Data Integrity.
Preferred Experience and Skills:
- Technical knowledge and experience with system and stand-alone software.
- Experience in new product introduction and technology transfer
- Ability to provide scientific mentorship and guidance to technical colleagues
- Lean Six Sigma belt certification
- Working understanding of process risk assessment tools
- Experience with face to face presentation of technically complex subjects to regulatory inspectors
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to email@example.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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Job: Qual Cntrl/Inspect Tech. Spec.
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name: Merck
Nearest Major Market: Raleigh
Nearest Secondary Market: Rocky Mount