Msd

Sr. Specialist, Quality Control

USA - Kansas - De Soto · Senior · Contract

Sponsorship not specified$106k-$167kDetected 6 days ago

ExcelSAPHRISGMPFDA RegulatoryResearchLeadershipCommunicationAdaptabilityMicrosoft OfficeRegulatory Affairs

About the role

This role combines project leadership/coordination and quality oversight to ensure successful QC laboratory method transfers.
Specialist will ensure laboratory processes and systems are in place to meet Quality Control testing activities associated with the method transfers.
Please click here if you need an accommodation during the application or hiring process.

Serve as the Project lead for the QC laboratory transfers.
Ensure teams are formed to support the project, and monitor timelines to ensure that each phase is completed on schedule, preventing delays.
Support completion of Transfer Complexity assessment.
Author the Quality Risk Management Plan, and support gap assessments.
Support Regulatory Affairs with Outline of Production/Special Outline updates
Strong attention to detail, excellent documentation practices, and ability to maintain audit-ready records.
Effective communication and interpersonal skills; ability to collaborate with cross-functional teams and external vendors.

Review/approve required test method information (spec sheets, tests, biomaterials/reagents, release criteria).
Bachelor's degree in Biology, Microbiology, Chemistry, Animal Science, Biotechnology, or equivalent experience;
Experience with USDA regulations and inspection processes in manufacturing environments
Relevant practical experience with QC laboratory environments, method transfer, or related quality roles in biologics, vaccines, or similar industries
Experience with qualification of facilities, equipment, instruments, and/or utilities.
Proficient with MS Office (Word, Excel, PowerPoint); experience with SAP and electronic quality management systems (Reliance, Veeva) preferred.

Experience leading or supporting method transfers and performing go-sees.
Strong project coordination skills and ability to work with cross-functional teams.
Experience with implementation of LIMS
Excellent written and verbal communication skills.
Physical and Work Environment
Primarily office-based with occasional travel between sites.
Ability to travel for site visits/go-sees as required.
Required Skills:

Laboratory Quality Control, Quality Management, Quality Management Systems (QMS)
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.
For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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The salary range for this role is
$106,200.00 - $167,200.00
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.S.
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

This listing is sourced directly from Msd's careers page and normalized into a canonical job model.