Sr. Specialist External Manufacturing Quality (Animal Health)

Job Description

We are seeking a Sr. Specialist, External Manufacturing Quality to ensure that all products supplied by North American Contract Manufacturers for API and Veterinary Products meet regulatory guidelines and customer demands.  The Sr. Specialist will act as our company's Animal Health Quality Operations point of contact to North America  CMOs as the Quality liaison between the external partner and the internal company personnel. The successful candidate will provide technical expertise in validation, quality systems, deviations, change control, equipment qualifications, and auditing. Join our dynamic team and play a key role in ensuring the highest quality standards for our Animal Health products.

Responsibilities:

• Oversee the total quality performance and operations of Contract Manufacturing Organizations (CMOs) in North America, ensuring adherence to Good Manufacturing Practices (GMP).
• Act as a liaison between external partners and internal company personnel, coordinating audits and subsequent remediation efforts.
• Conduct audits of suppliers and CMOs, handle deviations and non-conformities, and ensure compliance with quality requirements on change proposals.
• Enforce validation requirements, initiate quality improvements, and contribute to cross-functional investigation and project teams.
• Review stability data, handle product quality complaints, and ensure timely completion of quality system activities.

Qualifications, Skills, and Experience:

• Bachelor's degree in science, engineering, or related discipline
• 5 years of experience with Quality Systems, GMPs, and regulations in a manufacturing environment
• Experience in handling product complaints, deviations, and change control management.
• Must be familiar with process and laboratory methods validation and equipment qualification.
• Strong problem-solving and risk management skills.
• Excellent interpersonal, communication, and leadership skills.
• Highly organized with attention to detail and ability to manage multiple priorities.
• Excellent oral and written communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proven organizational and time management skills.
• Auditor training preferred.

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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.

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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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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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