Merck & Co Hiring for Senior Specialist, Quality Assurance job in Rahway Full Time

The Senior Specialist, Quality Assurance will be responsible to build and maintain the clinical supply chain for sterile dosage drug product manufacturing at the Rahway, NJ site. This role will manage and execute GMP quality assurance activities directly related to internal and/or external sterile drug product production and batch release for clinical trial material supply. This role must assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet our Company’s quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations.

Essential Duties and Responsibilities:

• Perform quality assurance activities for drug product manufacturing in clinical development.
• Ensure all drug products are manufactured in compliance with cGMP and regulatory filings.
• Review and approve quality investigations of events or non-conformances, complex and non-routine issues.
• Review and approve batch production records, raw materials, intermediates, finished dosage forms; all related documentation, investigations, deviations, change records, etc. for each batch.
• Ensure procedures are followed and specifications met to release or reject materials.
• Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.
• Establish, educate, and enforce standard operating procedures required under GMP.
• Participate or lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
• Maintain a state of readiness for and participate in audits and inspections.
• Support operational readiness and future GMP operations of new sterile manufacturing facility, and existing facility upgrades or renovations.
• Perform quality assurance activities related to sterile drug product manufacturing in a complex, clinical supply development. Review and/or approve GMP documents.
• On-site support of facility & staff (minimum 60% on a weekly basis)

Education Minimum Requirement:-

• Bachelor’s degree in a science, engineering, or related discipline; an advanced degree or certification in a management, technical, quality, or regulatory discipline will be preferred.-

Required Experience, Knowledge, and Skills:-

• Minimum of 5 years of experience in Pharmaceutical or Biotechnology industry role(s).
• Strong knowledge and application of Current Good Manufacturing Practice (cGMP).
• Direct experience in GMP quality, operations, or laboratories. GMP experience at the interface between quality and either an internal manufacturing or laboratory function or external contract manufacturing, laboratory, or related operations.
• Strong interpersonal skills including verbal and written communications, collaboration, teamwork within and across functions, conflict resolution.
• Demonstrated ability to manage projects and priorities, to meet deliverables and timelines.

Preferred Experience and Skills:

• Sterile dosage drug product (vial, syringe, other) manufacturing and/or analytical testing.
• A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include: quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment or facilities management.
• Diverse experiences in a GMP environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, cleaning, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.
• Ability to identify, focus, and solve problems in a timely and efficient manner.
• Experience with quality audits and EU regulatory inspections.
• Experience or working knowledge of R&D or clinical supply areas and processes.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). -Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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.

Expected salary range:
$97,680.00 – $153,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. – For Washington State Jobs, a summary of benefits is listed here .

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:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R263800