Senior Quality Specialist

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

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.

We are seeking a Senior Quality Specialist in West Point, PA. The Senior Quality Specialist, with guidance from the Integrated Process Team (IPT) Quality Operations Director or Manager, ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace. In this role you will be accountable for ensuring adherence to Divisional, Company and Site policies, procedures and guidelines. The Senior Quality Specialist position requires strong quality, analytical, scientific skills, as well as leadership abilities in order to manage Quality Operations (QO) within their team. Strong collaboration, communication, and decision making are necessary to be successful in this role. Key elements of this position are also detailed process and facility knowledge and frequent shop floor presence.

Job Duties
  • Acts as a primary QO contact for assigned area
  • Oversees a wide variety of process, analytical, chemical, microbiological, instrument and automation disciplines associated with operations
  • Accountable for the shared operations, quality and technology objectives for their area within the IPT, including deviationand discard reduction, schedule adherence, cycle time reductions and right first time
  • Coordinates and executes all Quality Operations activities to ensure production plans are met, utilizing the tier process
  • Assists with project work in the building
  • Review and release of drug product for downstream packaging for both domestic and international markets
  • Manages aspects of the material control and/or release process as it relates to control of material for deviations and riskprocessing
  • Initiates and conducts review and approval for investigations, CAPAs, QCTS commitments, change requests, risks, IQ/OQ/PQ, validation, Master Batch Records (MBRs), LIMS CRs, etc.
  • Conducts GMP walkthrough inspections to ensure compliance with cGMPs and regulatory requirements
  • Actively participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative for the IPT
  • Support in the preparation of regulatory filings
  • Write, review, approve SOPs and other instructional documents for shop floor
  • Provides training to incoming personnel and ensures compliance with departmental procedures
  • Completes duties of Quality Manager in their absence


Required Qualifications
  • Bachelor's degree in a science, engineering, or related areas of study
  • Minimum five (5) years of working in a pharmaceutical, biotech, or another related industry
  • Demonstrated leadership expertise working with cross-functional teams
  • Strong verbal and written communication skills
  • Effectiveness and creativity in approaching and solving technical problems
  • Attention to detail, flexibility and an awareness of production and attendant quality control problems
  • Demonstrated comprehension of cGMPs and regulatory requirements (domestic and international)


Preferred Qualifications
  • Proficiency in project planning and execution
  • Aseptic/Sterile processing


Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed 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 ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R142965