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Job Details


Merck & Co, Inc

Quality Assurance Complaints Specialist

Equipment/Technology Specialist

Equipment and Facilities Specialist

No

West Point, Pennsylvania, United States

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Assurance Center of Excellence is the 'Voice of Quality' for the Site and is responsible for providing Quality direction and oversight to the WP Site in the management of those areas assigned, such as general End-to-End Support, Product Quality Complaints & Adverse Events, Market Actions, Internal Auditing, Training, Annual Product Review, Change Control, Inspection Management, Documentation, Manufacturing Batch Records, MES, Quality Planning, and Risk Management in order to maintain compliance with Regulatory requirements. The individual has a key role in the execution of WP Site and our Manufacturing Division priorities. The Quality Specialist is responsible for execution of activities within their assigned areas. The individual is responsible for the execution of Quality Systems at the West Point site in accordance with cGMPs and international regulations, our Company guidelines, procedures, and policies. In addition, the individual is expected to identify and implement continuous improvement activities in their assigned area.

Primary activities include, but are not limited to:

  • Processing of customer complaints received against finished products including handling of returned customer complaint samples.

  • Perform Adverse Event investigations and support compilation and analysis of PQC and AE data for Complaint Unit business processes.

  • Support Market Action activities including BPDR/FAR submission, Fact Finding, and Recall

  • Authoring Annual Product Reviews (APRs).

  • Run queries / reports / metrics in support of business processes

  • Update Standard Operating Procedures (SOPs) related to these business processes as needed.

  • Participate/support compliance projects to sustain and/or enhance compliance

  • Participate/support projects to enhance efficiency and effectiveness

  • Support ad-hoc data requests and analysis

  • Author, review, and approve procedures and other control documents.

  • Assist with aspects of Regulatory Inspections and commitments

  • Participate in internal audits and shop floor inspections

  • Performing gap analysis and remediation

  • Quality Support/ownership for applicable automation systems

  • Regulatory surveillance

  • Conduct training on compliance topics

  • Execute projects as required by the Associate Director

  • Individual may have the opportunity to support other areas within our Manufacturing Division West Point Quality

Assurance organization, including:

  • SOP and Batch Record Management

  • Process Change Management

  • CAPA Management

  • Audits and Inspections

  • Automation Compliance

  • Deviation Management

  • Inspection Management, QMS / Quality Council Management

  • Quality Risk Management

Education Minimum Requirement:

  • Bachelor's degree is required.

  • Degree in life science, scientific discipline or engineering preferred.

Required Experience and Skills:

  • Experience working in a GMP environment, direct experience with Documentation Review and/or Control, or prior experience supporting Regulatory Agency Inspections is required.

  • In lieu of a Life Sciences degree, equivalent, direct experience of 6 years is required as a minimum.

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.

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, 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”.

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R266116