Specialist, Quality Control

Job Description

Our Quality 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.

GENERAL SUMMARY:

Our Company is expanding its global vaccine production by adding an end-to-end laboratory capability located in the Durham, NC campus. The facility will be used to produce the bulk active ingredient, finished product, and laboratory testing for vaccine.

The Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing for product. Initially the position will focus on microbiology and sterility testing readiness in preparation for commercial production. The selected candidate will participate in assay development, assay validation, equipment validation, and GMP laboratory readiness. The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples, including bulk vaccine, filled vaccine, and media. The successful candidate will support the microbiology testing laboratories with emphasis on microbiological methods such as microbial enumeration, bacterial endotoxin (of support systems), and sterility (of in-process materials and finished product). The selected candidate will also be expected to review and authorize testing results, collaborate in day-to-day lab scheduling, provide leadership in lean lab initiatives, have a strong understanding of Labware Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support.

GENERAL PROFILE:

• Collaborate with internal customers and vendors to identify, evaluate, and implement new analytical technologies that expand site capabilities. Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and budgeting.
• Build knowledge of the company, processes, and internal/external customers
• Build and maintain strong relationships with site leadership, stakeholders, and customers
• Build relationships to work in a highly functioning diverse team environment
• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
• Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing
• Capability to function effectively within an automated/electronic laboratory environment
• This position will be located at the Durham, NC site.
• Occasional overtime and weekend support maybe required based on business needs.
  

BUSINESS EXPERTISE:

• Understands the fundamental business drivers for the company; uses this knowledge in own work
• Understands and applies regulatory/ compliance requirements relative to their role
• Influence, motivate, and energize individuals at all levels in the organization

FUNCTIONAL EXPERTISE:

The Quality Operations Laboratory Specialist will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to include the following:

• Microbiology and sterility assay qualification, including but not limited to microbial enumeration testing, endotoxin, rapid microbiology methods, compendial sterility testing and non-compendial sterility testing.
• Microbiology and sterility routine testing, including but not limited to microbial limits, endotoxin, rapid microbiology methods, compendial sterility testing and non-compendial sterility testing.
• Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods
• Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Corrective/Preventative Actions
• Execute test method qualification
• Trouble-shoot equipment issues as needed
• Has knowledge of cell culture propagation and maintenance procedures, and/or microbiological laboratory procedures
• Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning
• Train and mentor laboratory analysts on test methods, techniques, and good documentation practices.
• Review of laboratory generated data and results
• Provide active support during audits and inspections (regulatory, internal, safety)
• Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations
• Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements
• Influence, motivate, and energize individuals at all levels in the organization
• Support our Manufacturing Division and Quality initiatives
• Additional project and routine testing support as required by vaccine analytical testing requirements
• Other duties as requested by management to support effective laboratory operations and performance metrics

Education Minimum Requirement:

• B.S. in Biological Sciences, with minimum of 2 years of laboratory experience

Required Experience and Skills:

• Experience with aseptic manipulations
• Exceptional pipetting techniques
• Good technical writing skills and high attention to detail.
• Previous GMP-laboratory experience
• Work independently and within a team environment
• Sterility testing (compendia or rapid microbiological methods) experience
• Growth promotion experience
• Experience with compendial microbiological testing such as (USP Chapters , , and )
• Schedule Tuesday - Saturday (8-hour day shift)

Preferred Experience and Skills:

• Experience with responding to regulatory questions with multiple agencies (FDA, EMA, etc.).
• Experience with assay development, validation, or technical transfers
• Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry
• Experience in regulatory agency inspections
• Experience in technical writing, including Standard Operating Procedures, laboratory investigations, and method transfer/qualification reports
• Experience in training of personnel

PHYSICAL REQUIREMENTS:

• Ability to sit, stand and move within work space for extended periods
• Ability to work standing in a laboratory environment for extended periods
• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling.

WORKING RELATIONSHIPS:

• Reports to Microbiology Manager
• Interacts with employees within own department
• Frequent interaction with employees from other departments and across our Company sites
• Interacts with representatives from regulatory agencies
• Interacts with external suppliers

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.

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. VETJOBS #EBRG

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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:

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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.

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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, generally Tuesday, Wednesday and either Monday or 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".

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 BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/27/2024

A job posting is effective until 11:59:59PM on the day BEFORE the 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:R306394