Job Description
Job Description 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.
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The main function of the Specialist, QC Deviation Management is to initiate/author laboratory deviations (Incidents and investigations) in response to Quality Control events.
Additional Responsibilities General - Interacts with other areas including Quality Assurance, Validations and Production as needed to collaborate on the resolutions of events.
- Supports the execution of CAPAs and continuous improvement actions.
- Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects
Business & Functional Expertise - Completes assignments in alignment with department objectives
- Authoring of Laboratory deviations and supporting deliverables such as investigational protocols, reports.
- Authoring of Corrective Action and Preventive Action , and Batch Quality Notifications
- Authoring Standard Operating Procedures
Problem Solving - Identifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department head.
- Performs robust root cause analysis leveraging on MPS tools (ECF, Causal Branching, LFT, Defense analysis, etc)
Impact Influence - Communicates information, asks questions and checks for understanding
Accountability - Accountable for own performance
Decision Making - Makes decisions - guided by policies and procedures - on the shop floor
- Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes
Shift 1st Shift Days (Mon-Fri) Education Requirement - Bachelor of Science degree in Biology, Chemistry, Biochemistry, or related field
Required Experience and Skills - Minimum 2 years related experience
- Understanding and application of Good Laboratory Practices and cGMPs
- Working in a team environment
- Deviation Management experience
Preferred Experience and Skills - Strong verbal and written communication skills
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Working Relationships - Reports to Quality Control department head
- Interacts with employees within own department and other departments
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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. Equal Opportunity Employment laws, visit:
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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.
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U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: -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.-
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: No Travel Required
Flexible Work Arrangements: Hybrid
Shift: 1st - Day
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 04/18/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R343749
Job Tags
Full time, Contract work, For contractors, Local area, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, Day shift, 3 days per week,