Senior Specialist, Quality Control Job in North Carolina (NC), Manufacturing Career, Full Time Jobs in Merck & Co.
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Senior Specialist, Quality Control job in Durham

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Merck & Co. jobs
North Carolina (NC), Durham
Job Code:  MERCUSR293114ENUS
Employer:  Merck & Co.
Category:  Manufacturing
Job Type:  Full Time

Location
Country:  United States
State:  North Carolina (NC)
City:  Durham
05/04/2024

Description
Job Description

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

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The Senior Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing of the vaccine product. The position will focus on environmental monitoring, aseptic process simulation and support testing readiness in preparation for commercial production.- The selected candidate will participate in equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples and media.

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The selected candidate will also be expected to review and authorize testing results, participate in day-to-day lab scheduling, provide leadership in lean lab initiatives, have a strong comprehension of Laboratory Information Management System (LIMS), handle Quality Notification authoring, lead project initiatives, and provide audit support.

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This position follows a 2nd shift schedule - Monday through Friday (2 p.m. - 10:30 p.m.)

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Job Responsibilities

The Senior Specialist, Quality Control will be accountable for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to include the following:
  • Lead for microbiology qualification, including but not limited to environmental monitoring, media testing and release, and clean utilities
  • Sampling of clean utilities including but not limited to compressed gas and water for injection
  • Environmental monitoring of production and support areas, including sampling, processing of samples, and reporting results
  • Participating in Environmental Monitoring Performance Qualification activities
  • Microbiological testing in support of production media
  • Participating in aseptic process simulations, including sampling, testing of simulation units, and reporting of data
  • Schedule daily testing of laboratory samples based on internal metrics and production needs
  • Author/review technical documents, method transfer/qualification reports, 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 Preventative Actions
  • Execute test method qualification
  • Trouble-shoot method and equipment issues
  • Sample management
  • Planning test method execution to meet established delivery timelines
  • 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
  • Authorizing and approving of samples
  • 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
  • Partner with 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
  • Other duties as requested by management to support effective laboratory operations and performance metrics
  • Partner 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
  • Accountable for quality and/or technical contribution to project team or sub-team
  • Support project team initiatives to ensure timelines are met and laboratories are prepared for routine product testing
  • Aware of costs and assists in controlling costs related to own work
  • Responds to standard requests from internal and external customers
  • Identifies and solves a range of problems in straight forward situations; analyzes possible solutions and assesses each using standard procedures
  • Comprehends 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

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Required Education and Experience
  • Bachelor's degree in Biological Sciences, or related areas of study with five (5) years of relevant pharmaceutical, biotech laboratory experience

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Required Experience, Knowledge, and Skills
  • Experience with Aseptic manipulations
  • Experience with Environmental monitoring activities
  • Sampling of clean utilities, including but not limited to compressed gasses and water
  • Environmental monitoring performance qualification
  • Good technical writing skills and high attention to detail
  • GMP-laboratory
  • Work independently and within a team environment
  • Laboratory investigations, root cause analysis methodology, and corrective/preventative actions
  • Developing, authoring, and/or revising Standard Operating Procedure
  • Has knowledge of cell culture and maintenance procedures, and/or microbiological laboratory procedures

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Preferred Experience, Knowledge, and Skills
  • Responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,)
  • Equipment Validation
  • Authoring or executing change control
  • Knowledge of CFR, Eudralex, and Compendia Ok specific to the pharmaceutical industry
  • Technical writing, including Standard Operating Procedures and method transfer/qualification reports
  • Implementation and troubleshooting of microbiological/biological assays.
  • Assay development, validation, or technical transfers

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.

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.

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, 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:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
2nd - Evening

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:05/08/2024

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:R293114
ref: (MERCUSR293114ENUS)
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