Hiring company: Merck
Job Description
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, 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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Primary Responsibilities
Provide quality oversight of the packaging process and plant site
Evaluate defect resolution and the control of material throughout the plant | Defect resolution, including use of statistical methods, and control of material throughout the plant site | Apply material control
Provide guidance to packaging operation to ensure compliance with Company Quality policies, GMP's and other agency regulations for application to Wilson Operations
Perform batch record review activities of intermediate/finished product
Maintains 5S organization and identifies improvement opportunities
Trends a variety of compliance performance indicators and works to drive compliance improvement
Participates in the implementation of new programs/regulations/divisional processes at the site
Identifies continuous improvement (business and compliance excellence) opportunities and through partnership and engagement with other functional groups, implements changes to processes
Provides Quality Assurance review and approval of GMP-related SOPs. Assist in the development of procedures to improve compliance status of Wilson operations
Participates in plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition, if required
Participates in projects, if required
Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents
Builds and promotes Team effectiveness through actions that demonstrate respect and appreciation for diverse perspectives
Ability to interpret Company Quality Policies and Guidelines for daily application
Education Minimum Requirements
Bachelor degree preferred | Candidates with an Associate degree will be considered pending relative experience | Minimum of an internship or one (1) year of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality, or Operations
Required Experience and Skills
Team Building through respect and diversity
Knowledge and exposure to fundamental theories, principles, and concepts in the Quality Assurance discipline , including the knowledge and understanding of pharmaceutical operations systems
Strategic comprehension and appreciation of customer needs, requirements and expectations
Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging Team members to make suggestions and share ideas
Technical writing capabilities and be able to compile straightforward investigations and procedures
One to four years pharmaceutical industry exposure
Comprehends and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace
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.
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.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
Pay Transparency Nondiscrimination
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.
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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not SpecifiedShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
Number of Openings:
1