Specialist, Laboratory Support

Job Description

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Position Description:

The successful candidate comprehends 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 our 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 our Company SDLC procedures. Possesses strong technical writing capabilities and is able to compile more complex investigations, procedures, justifications, qualifications/validation protocols, etc. Ability to objectively 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 Responsibilities

• As a site change control process steward, works with site members and/or global team for oversee QO lab change control process
• Master all skills for our Company Risk Assessment Management and our Company Supplier Transparency management
• Comprehend the process of Deviation management and proficient to complete required deviation investigation toward the closure within required time line
• Works with PM mechanical and or vendors to ensure Equipment Qualification and Calibration on time of schedule, protocols and process
• Promotes 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 activation's are completed and on-track of schedules or possible obstacles
• Demonstrates in-depth comprehension 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 and 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 our Company Analytical Standards, if applicable
• Provides technical and analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers
• Ensures laboratory compliance by adhering to cGMP, CFR, EU and other agency regulations
• 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 our Company Data Integrity Center of Excellence

Education Minimum Requirement

• Bachelor degree in Chemistry, Chemical Engineering, or related chemistry field

Required Experience and Skills

• Minimum of three (3) years of experience in Laboratory GMP Equipment Qualification in a regulated environment
• Three (3) plus years in a pharmaceutical manufacturing and cGMP environment
• Three (3) plus years in SDLC
• Three (3) plus years authoring technical documentation within a cGMP context
• Proven technical communication (written & presentation) skills
• FTIR, HPLC, UV/VIS, NIR, and their software
• Change Control and Data Integrity
• Quality, Safety and regulatory Risk Assessment

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
• Working understanding of process risk assessment tools
• Face to face presentation of technically complex subjects to regulatory inspectors
• Compile complex investigations, procedures, justifications, qualifications/validation protocols, etc.
• Possesses an advanced knowledge and ability to master multiple instruments required to complete job responsibilities with the ability to sufficiently troubleshoot from these instruments
• Identifies improvement opportunities and both independently and as a facilitator of change, implements improvements. Learns a variety of tools to drive continuous improvement (ex: lean six sigma, human error prevention, etc.)

Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R124909