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Job Details


Merck & Co. Inc.

Senior Specialist, Quality Assurance

Pharmaceuticals

All

Full Time

On Site

No

Elkton, Virginia, United States

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 a codependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Senior Specialist Quality Assurance, with guidance from the Quality Operations Leader, ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products. He/she is accountable for ensuring adherence to Divisional, Company and Site policy, procedures and guidelines.

The Senior Specialist Quality Assurance position requires strong quality/analytical/scientific skills, as well as leadership abilities in order to manage Quality Operations within their team. Strong partnership, communication, and decision making are needed. Key elements of this position are also detailed process and facility knowledge and frequent shop floor presence.

The Senior Quality Assurance Specialist will be accountable for:

  • Acts as a primary Quality contact for their area of support. As such, the incumbent will have sound knowledge of process, GMP systems, regulatory guidelines, design standards, company policies, as well as local SOPs .

  • He/she is accountable for the shared operations, quality and technology objectives for their area, including deviation and discard reduction, schedule adherence, cycle time reductions and right first time.

  • Aids in coordination and execution of Quality Operations activities to ensure production plans are met, utilizing the tier process.

  • Supports project work in area of responsibility.

  • Serves as back-up to the Release Coordinator and helps to manage aspects of the material control and/or release process as it relates to control of material for deviations and risk processing.

  • Performs review and approval for investigations, CAPAs, QCTS commitments, change requests, risks, IQ/OQ/PQ, validation, Master Batch Records (MBRs), etc.

  • Performs 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.

  • Write, review, approve SOPs and other instructional documents for shop floor.

  • Provides training to incoming personnel and ensures compliance with departmental procedures.

  • Participate in workshops, design review meetings, risk assessments, protocol reviews, and roll-out activities associated with continuous improvement projects within the area.

  • Provide Quality guidance and assistance in deviation identification and initiation

  • May perform the tasks or manage a small number of people who will be accountable for Quality Assurance activities supporting the production process.

  • Performs duties of Quality Manager in his/her absence.

Education

  • At least a Bachelor's degree in Science, Engineering, or related areas of study.

Required

  • Minimum of five years experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including regulatory requirements.

  • Strong contemporary knowledge of relevant cGMPs and regulations and current industry trends.

  • Strong decision making skills.

Preferred

  • Strong knowledge of Pharmaceutical Manufacturing, SAP, TrackWise and project management.

  • Supervisory and management experience a plus.

  • Ability to correspond with all levels of site and our manufacturing division organization through all means (written, verbal, presentations, etc.)

  • Ability to work with and interact with off-site customers.

  • Detailed knowledge of areas impacting direct area of responsibility.

  • Proven ability to lead self-directed teams.

  • Demonstrated ability to manage complex projects.

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 [Register to View] 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.

Residents of Colorado

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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 [Register to View] if you need an accommodation during the application or hiring process.

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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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R131616