Hiring company: Merck
Job Description
If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
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.
At our Company Manufacturing facility in Elkton, Virginia, we currently have a Quality Assurance (QA) Manager position available at the Stonewall Plant, which is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains. The facility is just a short distance from major state universities: University of Virginia and James Madison University.
The manager will manage the oversight of Quality Assurance related activities of biologics drug substance product and the associated salaried workforce to ensure attainment of compliance and business results. The incumbent will effectively collaborate within a team environment with the responsibilities of quality related execution activities, effective administration of personnel performance policies and procedures, management of conflict and change, and the identification and implementation of continuous improvement initiatives. The manager will work with technical and operational staff in supporting equipment startup, process and area qualification, SOP and training development, process validation, and the training and development of the Quality Assurance staff to support commercial demand in a biologics manufacturing facility. The manager will perform and participate in safety, environmental, and quality audits and investigations and be involved in implementation of related corrective actions. The manager will ensure that supervised personnel execute their tasks Right the First Time per standard operating procedures and in compliance with cGMPs, safety, and environmental regulations. Due to the high impact nature of this role, it is essential that the incumbent demonstrate integrity, credibility, and flexibility in their daily performance so as to motivate others to do the same.
Additional responsibilities also include but are not limited to:
Acts as a primary Quality contact for their area of support. As such, he/she must have sound knowledge of process, GMP systems, regulatory guidelines, design standards, company policies, as well as local SOPs.
He/she is accountable for the shared operations, quality and technology objectives for their area, including deviation and discard reduction, schedule adherence, cycle time reductions and right first time.
Aids in coordination and execution of Quality Operations activities to ensure production plans are met, utilizing the tier process.
Supports project work in area of responsibility.
Serves as back-up to the Release Coordinator in some cases and helps to manage aspects of the material control and/or release process as it relates to control of material for deviations and risk processing.
Performs review and approval for investigations, corrective and preventative actions CAPAs, regulatory commitments, change requests, risks, validation protocols, Master Batch Records (MBRs), standard operating procedures (SOPs), etc.
Performs GMP walkthrough inspections to ensure compliance with cGMPs 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.
Writes, reviews, approves SOPs and other instructional documents for shop floor.
Provides training to incoming personnel and ensures compliance with departmental procedures.
Participates in workshops, design review meetings, risk assessments, protocol reviews, and roll-out activities associated with continuous improvement projects within the area.
Provides Quality guidance and assistance in deviation identification and initiation
May perform the tasks or manage a small number of people who will be responsible for Quality Assurance activities supporting the production process.
Performs duties of Quality Assurance Associate Director in his/her absence.
This position will work various shifts during startup, media challenge and process validation periods, and ultimately be on a daylight (first) shift.
Education Minimum Requirement:
Bachelor’s degree required - concentration in Chemistry, Chemical Engineering, Pharmacy, Biology, Microbiology, or equivalent.
Required Experience and Skills:
Minimum three years of experience in the pharmaceutical, manufacturing industry or applicable scientific discipline.
Knowledge of Quality Systems, Quality Assurance, and Quality Control including regulatory requirements.
Strong contemporary knowledge of relevant cGMPs and regulations and current industry trends.
Preferred Experience and Skills:
Experience with biological processes such as fermentation, Tangential Flow Filtration operations, and low and high pressure chromatography
Leadership and interpersonal skills to motivate direct reports and peers to excel and "own" the process. Supervisory and management experience a plus.
Ability to communicate with all levels of site and our Manufacturing Division organization through all means (written, verbal, presentations, etc.)
Lean, Six Sigma problem-solving skills coupled with a continuous improvement mindset
Demonstrated ability to manage complex projects
Delta V and SAP experience is a plus
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 …
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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Work WeekShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/ANumber of Openings:
1