Specialist, Quality Control-1 Position Available In Durham, North Carolina

Job Description

GENERAL SUMMARY

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

The Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing for the BCG 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. 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 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 customersBuild and maintain strong relationships with site leadership, stakeholders, and customersBuild relationships to work in a highly functioning diverse team environmentApplies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goalsUnderstand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testingCapability to function effectively within an automated/electronic laboratory environmentThis position will be located at the Durham, NC site. Short periods of travel may be required as needed for training.

BUSINESS EXPERTISE

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

FUNCTIONAL EXPERTISE

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

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, standard operating procedures, change controls, and investigations for the performance of laboratory methodsInitiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Corrective/Preventative ActionsExecute test method qualificationTrouble-shoot equipment issues as neededLaboratory maintenance including managing stock of reagents, consumables, and laboratory cleaningTrain and mentor laboratory analysts on test methods, techniques, and good documentation practices.

Review of laboratory generated data and resultsAuthorizing and approving of samplesProvide 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 registrationsCollaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirementsInfluence, motivate, and energize individuals at all levels in the organizationSupport our Manufacturing’s Divisional and Quality initiativesAdditional project and routine testing support as requiredOther duties as requested by management to support effective laboratory operations and performance metrics

PROBLEM SOLVING

Identifies and solves a range of problems in straight forward situations; analyzes possible solutions and assesses each using standard procedures

INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS

Responds to standard requests from internal and external customers

IMPACT:

Errors on the job may cause time delays and impact the work of others in own work group or potentially impact product disposition

Influence and Decision Making:

Explains information and persuades others in straightforward situationsMakes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlinesEscalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality

PROJECT MANAGEMENT

Accountable for quality and/or technical contribution to project team or sub-teamSupport project team initiatives to ensure timelines are met and laboratories are prepared for routine product testing

RESOURCE MANAGEMENT

Aware of costs and assists in controlling costs related to own work

QUALIFICATIONS

RequiredB.S. in Biological Sciences, with minimum of 3 years of laboratory experienceExperience with aseptic manipulationsExperience with environmental monitoring activitiesExperience in sampling of clean utilities, including but not limited to compressed gases and water.

Good technical writing skills and high attention to detail.

Previous GMP-laboratory experienceWork independently and within a team environment

Preferred:

Experience with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,).Experience authoring technical documents supporting regulatory filings (IND,BLA)Experience with assay development, validation, or technical transfersEquipment ValidationKnowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industryExperience in regulatory agency audits and/or regulatory filingsExperience in technical writing, including Standard Operating Procedures, laboratory investigations, and method transfer/qualification reportsExperience in training of personnel

PHYSICAL REQUIREMENTS

Ability to sit, stand and move within work space for extended periodsAbility to work standing in a laboratory or production environment for extended periodsAbility to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pullingAbility to travel

WORKING RELATIONSHIPS

Reports to Microbiology ManagerInteracts with employees within own departmentFrequent interaction with employees from other departments and across our company sitesInteracts with representatives from regulatory agenciesInteracts 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.

VETJOBS #EBRGCurrent Employees apply HERECurrent Contingent Workers apply

HEREUS 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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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SupplementWe are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 ActsU.S. Hybrid Work ModelEffective 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, Monday – 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”.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the

San Francisco Fair Chance OrdinanceLos Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read CarefullyMerck & 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:

RegularRelocation:

No relocation

VISA Sponsorship:

NoTravel Requirements:

10%

Flexible Work Arrangements:

Not ApplicableShift:

1st –

DayValid Driving License:

NoHazardous Material(s):

N/AJob Posting End Date:

05/3/2025•A job posting is effective until 11:59:59PM on the day BEFOREthe 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:

R346307PDN-9ec3c50b-5519-481e-afd4-d5c19064c473