Manager, Quality Control
Manager, Quality Control
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Job Description
Job Description
Responsibility:
- Align relevant quality systems with the intent of our companys animal health quality manual and where required develop and document a rationale for differences between local requirements and quality manual core requirements.
- Provide leadership in ensuring the quality of the products that meet established specifications.
- Testing of all applicable samples in compliance with applicable GMP regulations and applicable Quality Manual Modules.
- Coordination of day-to-day quality control-related activities with other departments (e.g. with Quality Assurance and IPT).
- Operate at the highest possible laboratory and personnel usage rates at minimum costs and with minimum failures.
- Ensure labs and equipment are calibrated validated and maintained as applicable to support analytical daily operations.
- Review and approve all documentation including specifications and test methods data records certificates of analysis andmethod validation documentation.
- Ensure all test methods required for tests of products on the Ningbo site are validated.
- Analysis of failures (OOS OOT and Atypical Results) and implement corrective and preventive measures in cooperation with Quality Assurance.
- Identify and implement improvements in the laboratories corresponding to the local and international requirements for GMP-compliant QC operations to include laboratory expansion as required by the increase in production volume.
- Appropriate training of staff. Achieve a high level of competence and ensure that they are motivated and can carry out their duties in a safe manner.
- Identify opportunities for continuous improvement within QC operations.
Qualifications:
Educational background: Bachelors degree or above in microbiology virology biotechnology veterinary medicine or related fields.
Working experience: 5 years or more experience in QC detection of veterinary vaccines or biological products and be familiar with the priority of swine poultry and pet dog vaccines. Participated in research and development of new swine/poultry vaccine products and was familiar with process transfer and methodological verification (specificity and sensitivity verification).
Core technical capabilities:
Viral testing (eg viral titer testing PCR/qPCR neutralization testing exogenous viral testing)
Microbial testing (eg sterility testing endotoxin testing mycoplasma testing)
Physicochemical analysis (pH purity residual moisture)
Regulatory compliance
Proficient in the GMP of veterinary medicine.
Familiar with the quality inspection standards for veterinary vaccines of the Chinese Veterinary Pharmacopeia (III) and the Ministry of Agriculture and Rural Affairs of China.
Team management: At least 3 years of experience managing a team able to coach provide feedback and support the teams development.
Cross-collaboration: Proficiency in cross-collaboration linking to R&D production and QA.
Quality management system: Leading Deviation investigation (OOS/OOT) CAPA implementation and laboratory risk assessment.
Develop/optimize SOPs test processes ensure data integrity and traceability.
Soft skills
Good problem-solving stress management and communication skills (reporting of quality risks to senior management)
Rigor for data integrity. Extreme data accuracy and detail.
Motivates teams to perform emergency testing tasks efficiently.
Adaptability: Flexibility to respond to changes in R&D project schedule and unexpected quality inspection needs.
Language ability: proficiency in English application good listening speaking reading and writing ability.
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Analytical Method Transfer Analytical Testing Analytical Thinking cGMP Compliance Construction Corrective Action Management Driving Continuous Improvement Failure Analysis GLP Regulations GMP Compliance GMP Documentation Laboratory Operations Laboratory Safety Leadership Management Process People Leadership Pharmaceutical Quality Control (QC) Preventive Action Quality Assurance (QA) Standards Quality Control Management Quality Management Quality Standards Staff Training and Leadership Team Supervision Technical WritingPreferred Skills:
Job Posting End Date:
09/30/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Manager
Employment Type
Full-Time
