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 West Point Quality Line Oversight Program will provide hands-on experience in pharmaceutical quality assurance on the production shop floor supporting our Company’s largest and most complex vaccine manufacturing plant site.
The targeted start date for this position will be in July 2022.
The program consists of a 12-18 month assignment and will be a direct manufacturing support role within our Quality Line Oversight team. This team rotates through the vaccine filling and packaging departments at the West Point site providing quality and compliance oversight to our 24/7 manufacturing operations.
Primary responsibilities involve:
- Quality checks of finished product including visual inspection of vials, syringes and packages
- Verification of appropriate line clearance between batches to prevent product mix-ups
Additional responsibilities include:
- Batch record review
- Shop floor auditing
- Internal/external audit support
- Partnering with Operations/Technology on continuous improvements in quality and efficiency
The shift structure for the position includes 12-hour day and night shifts which rotate approximately every two months. The position does require weekend coverage.
This is an entry level position, and 0-2 years of experience in pharmaceutical industry through internships, co-operative education or other roles is preferred.
- Contributes to the performance and results of a vaccine manufacturing department.
- Provides regulatory, quality and compliance guidance.
- Applies technical, collaboration and interpersonal skills to align activities with department objectives.
- Works as a team member on shop floor audits, quality systems activities and/or process improvement projects.
- Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
- Assures consistent application of standardized work, process tools, and procedures.
- Assists with regulatory inspections in either documentation area, request management area or inspection room.
- Provides quality guidance to technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
- Effectively collaborates with peers on site and above site as required.
Education Minimum Requirement:
- Candidates must have B.S. Degree in Engineering or Sciences
Required Experience and Skills:
- Candidates must be willingness to work alternate shifts and weekends
- Candidates must have ability to focus on and obtain results
- Candidates must have good verbal and written communication skills
- Candidates must have ability to effectively collaborate within and across an integrated manufacturing team
- Candidates must have ability to enact conflict resolution
- Candidates must have ability to effectively respond to change
- Candidates must have excellent analytical and organizational skills
- Candidates must have high personal integrity, credibility and energy
- Candidate must have flexibility to perform related tasks to support the business
- Candidates must have computer literacy in MS Office, Word, Outlook, Excel
Preferred Experience and Skills:
- Candidates should have 0-2 years working experience in cGMP pharmaceutical environment
- Candidates should have experience using Lean/Six Sigma tools
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 …
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.