Merck Senior Specialist, Quality Assurance in Elkton, Virginia
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 a codependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Quality Assurance Senior Specialist partners with the Integrated Product Team to ensure product/process quality by reviewing Good Manufacturing Process (GMP) documents, promoting GMP process and facility improvements, participating in audits, and supporting activities to ensure the reliable release of quality products to the marketplace and is responsible for ensuring adherence to Divisional, Company and Site policy, procedures and guidelines.
The Senior Specialist Quality Assurance position requires strong quality, analytical, and scientific skills, as well as leadership abilities in order to sponsor a diverse, collaborative team. Strategic and effective collaboration, communication, and decision making are important aspects. Key elements of this position are also detailed process and facility knowledge and frequent shop floor presence is expected.
The Senior Specialist, Quality Assurance acts as a primary Quality contact for their area of support, and must have applicable knowledge of a wide variety of process, analytical, chemical, microbiological, instrument and automation disciplines associated with operations. The successful candidate is accountable for the operations, quality and technology objectives for their area, including deviation and discard reduction, schedule adherence, cycle time reductions and right first time. Coordinates and executes all Quality Assurance activities to ensure production plans are met, utilizing the tier process and promotes project work in the building.
Deviation investigations by training shift QA in deviation management procedures and practices | Supports technical operations during investigations
Performs review and approval for investigations, corrective and preventative actions, regulatory commitments, change requests, risk assessments, validation protocols, master batch records, standard operating procedures, etc.
Participates in workshops, design review meetings, risk assessments, protocol reviews, and roll-out activities associated with continuous improvement projects within the area
Manages aspects of the material control and/or release process as it relates to control of material for deviations and risk processing
Performs GMP walkthrough inspections to ensure compliance with expectations and regulatory requirements
Actively participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative | Sponsors the preparation of regulatory filings
Write, review, approve standard operating procedures and other instructional documents for shop floor
May perform the tasks or manage a small number of people who will be responsible for Quality Assurance activities supporting the production process
Provides training to incoming personnel and ensures compliance with departmental procedures
Performs duties of Quality Assurance Associate Director in his/her absence
- Bachelor's degree with concentration in Chemistry, Chemical Engineering, Pharmacy, Biology, Microbiology, Engineering, or related areas of study.
Experience and Skills
Minimum five years experience in the pharmaceutical industry or manufacturing environment.
Knowledge of cGMPs, Quality Systems, Quality Assurance, and Quality Control including regulatory requirements
Strong technical knowledge of vaccine manufacturing, including cell culture, fermentation, chromatography, open aseptic processing, and environmental monitoring
Previous management/supervisory experience is desired.
SAP | TrackWise | Project Management
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
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.
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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.
No Travel Required
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R100797