Job Description

Job Description

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

In partnership with Good Laboratory Practice Quality Assurance (GLPQA) Functional and Operation Leads, this role will assist the implementation of the Quality Assurance (QA) strategy. Working under minimal supervision facilitates specific tasks in compliance with appropriate government regulations (e.g., FDA Good Laboratory Practices (GLPs), OECD guidelines), guidance documents, Company policies and departmental standard operating procedures (SOPs). This position is accountable for the execution and closure of the assigned GLP QA audit activities ensuring that the current regulations, policies and procedures are adhered to at all of our Company's sites (domestic and international) and at contract facilities worldwide. Assignments are of moderate complexity. May act as a team or project lead and lead work of others as required promoting open discussion of issues. This role will act as a resource for colleagues with less experience. Primary activities include but are not limited to:

Primary Responsibilities:

* Independently function as a lead auditor, or as part of a team to ensure compliance to good practices (GxPs), international guidelines, our Research & Development Division's policies and departmental SOPs.

* Provide GLP regulatory perspective or quality advice and guidance to the stakeholder areas.

* Proactively identifies, analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies.

* Conducts wide range of GLP, regulated Bioanalysis/Bioequivalence/Vaccine Clinical Assay and Controlled Substance audits in accordance with QA risk-based processes. This includes audits of GLP study activities, study reports, vendor evaluations, facilities against applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards.

* Acts as a technical resource and is called upon to resolve GLP or regulated lab area issues and participate in the development/enhancement of QA procedures, guidance documents and audit tools to ensure global GLPQA consistency. Ensures appropriate and timely escalation of quality issues, including issues of significant deviation with projects, to the Functional Lead and GLPQA Head.

* Participates in the assessment of potential root cause and Corrective Action and Preventive Action (CAPAs) associated with Significant Quality Issues, as needed.

* Assures timely resolution of findings and reports all findings to appropriate personnel and management.

* Participate and or contribute to GLP awareness sessions.

* Contributes to the QA strategy and promotes QA objectives.

* Provide regulatory inspection management assistance as appropriate. Completes special projects or assignments as directed by management.

* Effectively partners with others (within our Research & Development Division's QA and external to QA) to accomplish quality goals; possesses group management skills.

* Demonstrates effective communication skills to convey and receive information.

* Demonstrates effective oral and written communication skills.

* Effectively solves basic problems using creative thinking, gathering data from appropriate stakeholders and answering to new or problematic situations in alignment with organization direction.

* Effectively organizes work efforts and utilizes resources to deliver or support work products in accordance with timelines and appropriate regulations.

Education Minimum Requirements:

Bachelors or Advanced degree in an appropriate science or equivalent field (e.g., biology, chemistry, etc.).

Required Experience and Skills:

Minimum of five (5 +) years experience in the pharmaceutical industry, or Quality Assurance and familiarity with GLPs and international guidelines is required or (3 +) years relevant experience with advanced degree.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

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.
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Work Week

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R97831