Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

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 sterility, bacteriostasis/fungistasis, Neomycin potency, Mycoplasma, and Mycobacteria. The analyst 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 authoring and provide audit support.

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

• Serve as the Microbiology subject matter expert for internal and regulatory inspections.

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

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

• Author and execute test method qualifications and final reports for microbiological assays.

• Has knowledge of cell culture propagation and maintenance procedures, and/or microbiological laboratory procedures

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

• Trouble-shoots equipment issues as needed

• Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions

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

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

• Supports our Manufacturing Division divisional and Quality initiatives

Qualifications

Required:

• B.S. or M.S. degree in Biological Sciences, with minimum of 5 years of laboratory experience

• Experience with aseptic manipulations

• Exceptional pipetting techniques

• Good technical writing skills and high attention to detail.

• Experience with execution and trouble-shooting of cell based and other microbiological/biological assays.

• Previous GMP-laboratory experience

• Work independently and within a team environment

• Sterility testing (compendia or rapid microbiological methods) experience

• Experience with compendial microbiological testing such as (USP Chapters <61>, <62>, and <85>)

• Experience with assay development, validation, or technical transfers

Preferred:

• Experience with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,).

• Equipment Validation

• Root cause analysis methodology

• Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry

• Experience in regulatory agency audits and/or regulatory filings

• Experience in technical writing, including Standard Operating Procedures and method transfer/qualification reports

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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:

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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, 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

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:

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Flexible Work Arrangements:

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Requisition ID:R331021