Senior Specialist, Quality Control
- Spring House, PA
Our Quality Control 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.
- Responsible for providing project and technical leadership for the Virology Technical Support Services Team.
- A primary goal of this individual is to provide excellent technical support to the Laboratory Operations area in support of schedule adherence, right the first time, and compliance goals.
- Support key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories.
- Strong partnership with Laboratory Operations, Laboratory Quality Assurance, Divisional Analytical groups, and manufacturing areas is required.
- Must be an advocate for maintaining a safe work environment and is responsible for ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and guidelines, policies and procedures.
- Expected to be a subject matter expert in testing performed using biological assays and to leverage this expertise to provide guidance for analytical changes, work standardization, and process improvements.
- Responsible for designing and driving projects, process improvements, as well as deviation and change management goals.
- Will leverage his/her experience and leadership skills for the development and mentorship of junior group members and peers.
- Will utilize his / her communication skills to present complex concepts and results to diverse audiences.
Education Minimum Requirement:
- Bachelor's Degree in Science, Engineering, or related areas of study.
Required Experience and Skills:
- At least 6 years of experience in GMP Manufacturing environment, People management, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting with a BACHELOR'S degree
- OR at least 3 years of experience in GMP Manufacturing environment, People management, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting with a MASTER'S degree
- OR have a PhD Degree.
- Experience with cell culture and cell-based assays
Preferred Experience and Skills:
- Experience with viral plaque assays
- Experience using SAP, LIMS, and Trackwise
- Progressive and demonstrated Quality decision making responsibility
- Project Management, Change Execution Management and Team Leadership experience in a Quality function
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment
- Proven analytical aptitude and critical thinking skills
- Demonstrated self-starter with capability to develop innovative solutions to challenges
- Strong written and verbal communication skills
- Comfortable with multi-tasking and working in a fluid environment
- In-depth working knowledge and application of GMPs/GLPs
- Experience in pharmaceutical laboratory operations or related environment
- Experienced investigator and the use of root cause analysis tools (E&CF, Fault Tree, Kepner-Tregoe)
- Speaks with courage and candor
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.
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.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at email@example.com
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
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:
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