Specialist, Quality Assurance - Hybrid

Job Description

The Clinical Supplies Quality organization, within our Research & Development (R&D) Division, is responsible for assuring the reliable availability, quality and regulatory compliance of clinical supplies in support of the clinical development programs for the R&D portfolio to enable the execution of all clinical trials (including more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced trials, 200+ IIS clinical trials and 200+ External Collaborations across 60+ countries) in accordance with worldwide regulations, company policies and standard operating procedures.

The Clinical Trial Regulatory Release auditor will have responsibility for releasing supplies to support our global clinical trials, ensuring regulatory release activities are performed in a timely and compliant manner to meet the portfolio needs. This position will require close collaboration and partnership with Global Clinical Supply, Global Clinical Trial Operations, Global Regulatory Affairs and Quality functions supporting the clinical supply chain to develop, implement and enable country release activities.

Primary Activities include, but are not limited to:

• Regulatory release of clinical supplies, ensuring compliance to applicable procedures to support global clinical trials.

• Assess Country specific requirements and conditions set forth by Health Authorities to ensure compliant release of clinical supplies.

• Author/support the authoring of procedures.

• Work closely with various business areas to ensure robust processing and continuous improvement throughout the end-to-end release process.

• Collaborate with Global Development Quality (GDQ) to implement an agile, end-to-end release process designed to improve efficiency and ensure compliance.

• Assist in projects aimed at reducing processing cycle times, contributing to overall operational excellence.

Required Experience and Skills:

• Comprehensive understanding of Clinical Trials and regulatory requirements

• Exquisite sense of urgency coupled with the ability to independently manage multiple priorities.

• Robust problem-solving abilities with a proactive approach to managing challenges.

• Background in quality control, quality assurance, auditing, Global Clinical Trial Operations, or regulatory affairs.

• Attention to detail, flexibility, and awareness of the end-to-end supply release process.

• Demonstrated teamwork skills and ability to work independently.

• Strong written and oral communication skills

Education/Experience:

• Bachelor’s Degree in Scientific Discipline with 2 years relevant experience within the pharmaceutical industry.

• Familiarity with batch disposition activities is preferred.

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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”.

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.

Expected US salary range:

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 listedhere.

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:

Regular

Relocation: