Job Description

Job Description:

We are seeking a Growth and Improvement minded Senior Specialist, Quality Operations that can help drive our Strategic Operating Priorities.

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges

The Senior Specialist, Quality Operations will serve as a member of the Quality Operations team providing knowledge for risk mitigation and contamination control. The candidate will gain a robust understanding of the aseptic processes and controls to ensure compliance and provide Quality support to site projects. The ability to work efficiently in a fast-paced environment, be hands-on, prioritize, analyze and review potential risks and gaps is a must. Assessment of process controls, documentation, gowning, equipment, materials, and facility will be required.

Off-shift or weekend coverage may be required, based on production schedule, or project-specific assignments to support business needs.

Primary Responsibilities:

• Gain robust understanding of the full manufacturing process, process requirements, environmental program, and Microbiology Laboratory Operations.
• Review environmental monitoring trends and data for continuous improvement.
• Prioritize and analyze potential issues that relate to Sterility Assurance
• Drive process improvements projects, company effectiveness, problem prevention.
• Review and author deviations, corrective and preventative actions, and SOPs.
• Participate in Quality Risk Assessments and initiatives.
• Train and mentor laboratory and operations staff on best practices, as needed.

Qualifications

Education Minimum Requirement with Experience

• Bachelor of Science Degree (BS) in Biological Sciences or related fields with six (6) years' experience in pharmaceutical operations, technical services, or quality operations.

Required Experience and Skills

• A minimum of 6 years in a quality function that supports compliance, release and/or environmental monitoring supporting a GMP manufacturing facility
• Working knowledge of GMP and regulatory requirements
• Aseptic technique and best practices
• Knowledge of contamination control, risk mitigation and sterility assurance
• Technical writing experiences such as SOPs, protocols, deviations, CAPAs, gap assessments
• Experience with Growth Promotion, Bioburden, Environmental Monitoring, Utility Testing, and Endotoxin
• Working both independently and within multi-functional teams
• Support of Quality projects and process improvement initiatives
• Strong writing skills and experience drafting study reports, scientific manuscripts, or scientific documents
• Experience with laboratory operations and data collection process
• Critical analytical skills

Preferred Experience and Skills

• Master of Science Degree (MS) in Biological Sciences or related fields
• Sterile manufacturing experience
• Aseptic Gowning knowledge and technique
• Ability to develop systems and teach/develop new employees
• Experience in GMP biologics manufacturing facilities, including preparation of PQ protocols, validation protocols and regulatory submissions.
• Knowledge of the manufacturing processes and support systems across the Durham organization
• Knowledge of CFR, EudraLex Annex 1 and other regulatory guidance specific to the pharmaceutical industry
• Strong analytical and problem-solving skills

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:

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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, 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:

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 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:R336398