02 May
Senior Specialist, External QA - Large Molecule
Pennsylvania, Westpoint

Job DescriptionOur 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 providing Quality Oversight of external parties, that manufactures biologics on behalf of our Company. Ensures that all biologic products manufactured at external partners and alliances are manufactured, packaged, analyzed, released, stored and distributed in accordance with our Company expectations and all applicable regulatory requirements.Remain informed of current GMP requirements and industry trends. Support review of regulatory filings, requests for information and subsequent supplemental packages as required. Advise support groups on aspects of GMP compliance. Support the development of GMP policies and procedures. Ensure all SOPs are aligned with current policies and applicable regulations. Build and maintain strong relationship with external parties. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities.Primary Responsibilities:

Participates in routine Tier 2 meetings with the external partner.

Supports the collection of QPI and Key Performance Indicator metrics in support of Quality Council and Calibrated Quality Oversight.

Reviewing executed batch records for completeness and compliance to all associated regulatory filings and executing the batch disposition process.

Management of transfer under quarantine requests and internal complaints.

Defining Quality requirements on Change Requests submitted by the external partner and ensuring conformance to all identified requirements prior to authorizing release of batches made under the changes; will ensure all validation expectations are met, where necessary, by on-site support for demonstration batches or validation batches.

Guides investigations conducted by the external partners' into abnormal operational occurrences such as batch rejections, atypical events, customer complaints etc. Coordinates support from appropriate staff groups and recommends corrective measures; assists in the coordination of significant investigations including Fact Findings and the coordination of product recalls as needed.

Manages the entry, coordination and completion of deviations and CAPA in COMET SAP system in accordance with timelines defined in departmental procedures.

Closely collaborates with appropriate business and operations areas to achieve our Company objectives.

Coordination and final assembly of the Annual Product Review package provided by the external partner.

Monitor the external partner to ensure that effective and robust Quality Systems and Quality management are in place.

Provides on-site guidance in the preparation of metrics, procedures and guidelines where warranted.

Operate in a safe and efficient manner and in compliance with our Manufacturing Division Quality Operations Safety and Health Policy.

Assure compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign

Education Minimum Requirement:

Bachelor’s degree or higher in a scientific or technical discipline

Required Experience and Skills:

Minimum of 5 years experience in the pharmaceutical industry with a thorough knowledge and broad experience of Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.

Hands on experience with change control processes in Global Change Management Trackwise.

Communicates in English, both verbally and in writing.

Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.

Preferred Experience and Skills:

Experience with biologic and/or vaccine Quality Assurance, Quality Control and manufacturing processes.

Hands-on experience working in COMET SAP for batch disposition, deviation management (including CAPA) and PCR Trace.

Excellent analytical and computer skills, including experience with SharePoint and Spotfire.

The ability to navigate in a complex environment with the ability to make ambiguous situations clear to stakeholders (e.g., process mapping, PowerPoint).

Strong leadership, collaboration, influencing skills along with Six Sigma / MPS experience.

Ability to work independently and interact with all levels of the organization.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.Who we are …Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.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 APPLICANTSIn 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.If you need an accommodation for the application process please email us at staffingaadar@merck.comFor more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprintposter.pdfEEOC GINA Supplement​ at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdfOFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdfWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:DomesticVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:Not SpecifiedShift:1st - DayValid Driving License:YesHazardous Material(s):Number of Openings:1Requisition ID: R50575

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