Senior Specialist, Quality Operations

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.

The QA Senior Specialist will serve as a member of the Shop Floor Quality Team, observing the manufacturing processes to provide real time risk mitigation with potential issues, questions and documentation. The candidate will gain a robust understanding of the processes to ensure compliance and provide Quality support throughout the area. The ability to work efficiently in a fast-paced environment, be hands-on, prioritize, analyze and review potential risks and gaps is a must. Assessment of process controls, documentation, gowning, equipment, materials, and facility will be required. Off-shift or weekend coverage may be required, based on production schedule, or project-specific assignments to support business needs.

Position Responsibilities:

• Member of the Shop Floor Quality Team, providing real time support to ensure compliance risk mitigation and sterility assurance
• Gain robust understanding of the full process and process requirements
• Manage and evaluate trends and data for continuous improvement
• Prioritize and analyze potential issues real time
• Troubleshoot process errors to drive process improvements, company effectiveness, problem prevention
• Review deviations, corrective and preventative actions, and SOPs
• Participate in Quality Risk Assessments and initiatives
• Train and mentor laboratory and operations staff on best practices as needed

Education Minimum Requirements:

• Bachelor of Science Degree in Science related field

Required Experience and Skills:

• Minimum of four (4) years of experience in a GMP related environment
• Working knowledge of GMP and regulatory requirements
• Aseptic technique
• Technical writing experiences such as SOPs, protocols, deviations, CAPAs
• Working both independently and within multi-functional teams
• Excellent communication skills
• Support Quality projects and process improvements

Preferred Experience and Skills:

• Sterile manufacturing experience
• Aseptic Gowning and technique
• Previous shop floor quality assistance
• Dependable, flexible, high attention to detail
• Audit and inspection support
• Trending reports and analysis
• Project management

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 ...

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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:R76952