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Quality Control Associate Specialist

4 weeks ago


Millsboro, United States Merck Sharp & Dohme Full time

Our Quality 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 Quality Control (QC) Associate Specialist, with Guidance from the QC Manager, ensures product/process quality through the review of GMP documentation and performs activities to ensure the efficient testing and reliable release of quality Animal Health products. This person is responsible for working closely with various departments in receipt, distribution, scheduling of QC tests, and review and release of antigen and seed batches. The QC associate specialist must adhere to regulatory and site policies and procedures governing the handling and release of product.

**Responsibilities**:

- Demonstrates, at all times, safe work habits and maintains a safe work environment. Understands and complies with all safety and company policies and procedures.
- At all times follow Good Manufacturing Practices, Quality Control Procedures (QCPs), Standard Operating Procedures (SOPs), and adhere to all safety and company policies, perform duties assigned by department management.
- Ensure product sample integrity for QC Testing
- Receipt, collection, distribution of samples for all QC testing areas
- Domestic and International shipments of testing samples
- Daily inter-departmental interactions and communications, as liaison for Quality Control, including the training of technicians on sample program and requirements
- SAP transactions, inventory control, GMP documentation and data integrity
- Responsible for the review and release of bulk antigen and raw material
- Drive process improvement using Six Sigma and MPS tools.
- Participation in project teams and/or complete design of special projects.

**Position Qualifications**:
**Education Minimum Requirement**:

- BS in related science discipline

**Required Experience and Skills**:

- 2 + years of experience in GMP Manufacturing environment, 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.
- Must possess thorough knowledge of the underlying principles used in testing procedures and understand the material being evaluated, i.e. virus, bacteria, cell line, etc.
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
- Demonstrated strength in communication, both written and verbal.
- Proven ability to effectively manage multiple and changing proprieties and projects and ensure timely completion.
- Proficiency with SAP and Office programs.
- Ability to work well independently, as well as part of a team

**Preferred Experience and Skills**:

- Knowledge of site and products
- Continuous Improvement, Lean, 5S experience
- Experience with record review and batch release

**NOTICE FOR INTERNAL APPLICANTS**

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.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

**US and Puerto Rico Residents Only**:
We are an Equal Opportunity Employer, committed to foste


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