West Point Quality Line Oversight Program
- Spring House, PA
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 Rotational Program is a multi-year program that 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 rotational program will include two 12-18 month assignments in West Point Quality. The targeted start date for this program will be in July 2021.
The first assignment will be a direct manufacturing support role within our Quality Line Oversight team providing quality and compliance oversight for our 24/7 manufacturing operations and rotating through the vaccine filling and packaging departments at the West Point site. The second assignment will be within either Quality Operations, Quality Assurance or Quality Systems at the West Point site.
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:
- B.S. Degree in Engineering or Sciences
Required Experience and Skills:
- Willingness to work alternate shifts and weekends
- Ability to focus on and obtain results
- Good verbal and written communication skills
- Ability to effectively collaborate within and across an integrated manufacturing team
- Ability to enact conflict resolution
- Ability to effectively respond to change
- Excellent analytical and organizational skills
- High personal integrity, credibility and energy
- Flexibility to perform related tasks to support the business
- Computer literacy in MS Office, Word, Outlook, Excel
Preferred Experience and Skills:
- 0-2 years working experience in cGMP pharmaceutical environment
- Experience using Lean/Six Sigma tools
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 ...
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.
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If you need an accommodation for the application process please email us at firstname.lastname@example.org
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We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
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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, 2nd - Evening, 3rd - Night
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