Job Description

The Quality Operations Laboratory Senior Specialist is accountable to support day-to-day operation of the Potency laboratory. The successful candidate will support testing, provide troubleshooting to test method and equipment related issues. The Senior Specialist 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 understand of Labware LIMS, handle Quality Notification, Change Controls, authoring SOPs and protocols and provide audit support.

Responsibilities

• Schedule daily testing of laboratory samples based on internal metrics and production needs

• Serve as a Subject Matter Expert (SME) for internal and regulatory inspections

• Provides active support during audits and inspections (regulatory, internal, safety)

• Participate in routine audits of Quality Operations laboratory to ensure compliance and inspection readiness

• Train and mentor laboratory analysts on test methods, techniques and good documentation practices

• Author and implement test method qualifications and final reports for assays

• Lead and support troubleshooting OOS and invalid assays. Provide scientific guidance for investigation

• Authors standard operating procedures (SOPs) for the performance of laboratory methods

• Trouble-shoots equipment issues

• Collaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirements

• Supports our Manufacturing Division divisional and Quality initiatives

• Bench work support

Education

• Bachelor's Degree in Chemical Engineering, or Scientific Field preferably biology, biochemistry or life sciences

Experience and Skills

Required

• Five years laboratory testing with a minimum three years in QC laboratory in a GMP settings

• Effective and principled technical writing skills with high attention to details

• Bioanalytical methods

• Various laboratory instrumentation

• Work independently and within a team environment

• Deviation support, change controls or method validation

• Principled communication skills

• Proven track record of successfully planning, executing, and troubleshooting projects and experiments

• Proficient with Microsoft Office: Word, Excel, PowerPoint

Preferred

• Mammalian cell culture (aseptic technique) | BSL-2 organisms

• Vaccine potency testing

• Trained in root cause analysis methodology

• Analytical method transfer

• Knowledge of method development and validation for use within the QC laboratory

• Equipment Validation

• Working knowledge of international regulatory guidelines, such as ICH, EP, JP

• Statistical data analysis with JMP or other software

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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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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, 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 Ordinance

Los 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 Ordinance

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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.

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Requisition ID:R324417