Specialist, Quality Assurance - Hybrid

Job Description

Quality Assurance Specialist (Hybrid)
The mission of Quality Assurance is to safeguard the rights and well-being of patients; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.

This position reports to the Associate Director of Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via related disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes direct support for batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (GMP) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications.

Duties may include, but are not limited to, the following:

Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations.

• Coordinate and/or support the preparation of procedures, processes and quality improvements.

• Assists in the coordination of significant quality events including fact-finding, investigation, coordination of clinical quarantine and recovery actions.

• Collaboration across Integrated Process Team (IPT) functional and business areas to ensure robust processing, continuous improvement, and cross-functional team building.

• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.

• Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.

• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans, when possible.

• Actively using and championing the use of Lean Six Sigma and our Company's Production System tools, both in problem solving and day-to-day operational activities.

Education:

• Bachelor's degree.

• Technical emphasis in an appropriate scientific or engineering field preferred.

Required Experience and Skills:

• Minimum of two years' experience in the Pharmaceutical or equivalent industry (GMP related field) including Technical, Engineering, Quality or Operations.

• Effectiveness and creativity in approaching and solving technical problems.

• In-depth working knowledge of current Good Manufacturing Practices and of regulatory requirements as they apply to the pharmaceutical field or a related area.

• Proficiency in using Microsoft applications (such as Excel, Outlook, PowerPoint, and/or Access).

• Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as stakeholder management and conflict resolution skills.

• Demonstrated teamwork skills and ability to work independently.

• Attention to detail, flexibility and an awareness of production and quality control problems.

Preferred Experience and Skills:

• Familiarity with batch disposition (release) activities is strongly preferred; prior batch disposition experience is a plus.

• Prior experience reviewing and approving investigations, deviation management, and Corrective/Preventative Actions (CAPAs)

• Previous background in quality control, quality assurance, auditing, or regulatory affairs.

• Ability to independently manage multiple priorities and projects.

• Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.

• Demonstrated analytical and problem-solving skills, knowledge of Lean Six Sigma and Project Management.

• Computer skills; knowledge and competency in Enterprise Resource Planning (ERP)/Manufacturing Execution Systems (MES), SAP and Veeva vault.

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:

EEOC Know Your Rights

EEOC GINA Supplement

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”.

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 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

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 BEFORE the 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:R334706