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 PM's, 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 metrics.Provides 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 Requirements

• Associate degree, preferably in Science with 2 years in a pharmaceutical laboratory setting; or

• Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with some experience in a laboratory setting

Preferred Experience and Skills

• Ability to quickly learn new processes, procedures, and equipment

• Knowledge and experience of CMMS systems is essential, ideally SAP

• Experience managing vendors and contractors

• Working knowledge of GMP's, Government regulations

• Good technical writing skills

• Some experience in audit scenarios

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA 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.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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

Search Firm Representatives Please Read Carefully
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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R329061