Organon - Specialist, External Quality Assurance

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 Product Quality Manager is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements.

Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP/ExP’s manufacture and release of (non-sterile pharmaceuticals, sterile pharmaceuticals, medical devices) by means of risk-based quality oversight and on-site supervision, as appropriate.

Position Responsibilities:

• Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of the company and compliance with all governing regulations; review and approve changes to master batch records

• Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer

• Provide support for audits of EP/ExP by Company and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted

• Oversee repackaging activities in the ExP/EP

• Conduct routine analytical change requests and support process modification change controls

• Stability Program management, including review of stability reports, and Annual Product Review assembly

• Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements

• Track and monitor operational and quality performance of the external manufacturer/partner

• Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine

• Support routine process validation; review and approve validation reports/tech transfer

• Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes

• Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums

Education Minimum Requirement:

• Bachelor' Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).

• Minimum of three (3) experience in the pharmaceutical industry with some knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred

Required Experience and Skills:

• Solves range of straight forward problems

• Receives moderate level of guidance and direction

• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals

• Responds to non-standard requests from clients and/or customers; investigations with assistance from others as needed

• Explains information and persuades others in straightforward situations

• Accountable for technical contribution to project team or sub-team; may manage/lead a small project team

• Ability to work across boundaries; developing interpersonal, relationship building and leadership skills

• Communicates easily in English both verbally and in writing

• Some knowledge of External Manufacturing management, supply chain, and operations

Travel:

• Ability to travel up to 25% of the time

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US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R86000