Associate Specialist, Quality Control, Lab Support

Job Description

Position Responsibilities:

• We are seeking a Growth and Improvement minded Technical Support Associate Specialist in Quality Control that can help drive our Strategic Operating Priorities.

• Invent Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute Prioritize Resources Behind Our Key Growth Drivers (Oncology Vaccines Select Specialty Areas Animal Health) While Optimizing Our Base Business)

• Adapt Develop Our People Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success They are a Competitive Advantage for Us

Summary Focus and Purpose

The Technical Support Associate Specialist QC is responsible for advanced preparation of maintenance jobs; responsible for maintaining equipment data preventive maintenance data and calibration data; processes change control for equipment and preventive maintenance documentation coordinates calibration program coordinates maintenance planning operations within the laboratory for consistency plans and schedules maintenance work orders schedules PMs maintains equipment histories analyzes equipment & preventive maintenance effectiveness and tracks maintenance metrics.

They demonstrate mastery of all maintenance management programs (Inventory Control Calibration Program Preventive Maintenance Program SAP Work Order Control etc.). Maintain positive vendor relations and support review/completion of vendor services. Assures compliance with FDA & GMP regulations. Demonstrates the ability to influence a team (including Global Support and Outside Vendors) in the effort to solve and execute corrective maintenance work and complete preventative maintenance work. Is a recognized resource to others when developing new maintenance reports standards and input in the management of Maintenance and Repair Budgets. Implements cost saving initiatives. Uses vast experience in maintenance to conduct in-depth review of maintenance planning responsibilities to suggest and implement process improvement ideas.

Key Functions

Development

• Work Independently and as a Team member with Integrity Precision Accomplishment Motivational Ambition Respect Inclusion

• Participate in development of objectives and ensures alignment with site goals

Laboratory Support

• Initiating/leading problem solving to identify short-term and long-term actions to prevent problem reoccurrence reduce laboratory downtime and increase equipment reliability

• Following standard work for escalation as it related to safety quality and downtime events

• Timely approval of qualification change control procedures and other documents

• Providing operational Subject Matter Expert support/direction for the installation of new equipment and/or modifications to existing processes and/or equipment

• Demonstrates a deep understanding of customer needs requirements and expectations.

• Pays close attention equipment use/maintenance and proactively steps in to help as needed.

• Maintains equipment preventative maintenance/calibration programs

Information Transfer

• Attends departmental and team meetings focused on equipment/process improvement

• Serves as liaison between NASU teams Leadership and External Vendors

• Ability to interpret our Company Quality Policies and Guidelines for daily application.

• Participates and/or Directs Tier Meetings

• Promotes teamwork and open discussion of issues.

Compliance

• Uses Root Cause Analysis tools to identify true root cause for quality and safety events

• Authors reviews approves and/or participates in quality investigations

• Participates in internal and external audits and inspections

• Identifies equipment-related trends and facilitates implementation of corrective actions

• Creates/Revises Standard Operating Procedures Forms and other equipment-related documents

• Understands and applies regulatory / compliance requirements including GMP NDA and related regulations and can interpret those regulations for implementation in the workplace.

Minimum Education Requirements

• Bachelor of Science degree preferably in Chemistry Biology or Engineering

Required Experience and Skills

• Prior experience in a pharmaceutical laboratory setting

• Knowledge and experience of CMMS systems is essential ideally SAP

• Experience managing vendors and contractors

• Working knowledge of cycle time and inventory management GMPs Government regulations

Required Skills:

Preferred Skills:

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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.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

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We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

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

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway 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.

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