Job Description

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 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 Manager is responsible for oversight of Quality Control activities to ensure timely release of high quality products to market. The Quality Control Manager is responsible for ensuring that the testing completed, and the results obtained in QC comply with internal and external regulatory guidelines. Personnel responsibilities involve daily contact with the technicians under his/her direct supervision, including acting as a technical advisor and "coach". The Quality Control Manager serves as a technical and administrative resource for other department personnel.

Responsibilities to include:

• The Quality Control Manager is responsible for managing the Quality Control and testing processes that support the facility, while actively supporting and participating in a team culture. Coordinate laboratory activities with the technicians. Ensure tests are performed within internal and external regulatory requirements and within established lead times.

• Review testing results and data and be able to identify abnormal events for escalation. Coordinate the preparation of QC metrics reports required for management meetings and discuss results at department or inter-department meetings. Advocate safety in performing tasks and perform periodic safety walk-throughs of the QC facility.

• Be actively involved in the hiring and training of technicians. Act as a mentor/coach for the technicians directly reporting to this position. Encourage development of direct reports to set and achieve objectives. Write and perform the performance evaluations of direct reports. Handle interpersonal conflicts.

• Provide leadership for the investigation of testing issues that may arise within QC. Actively participate as needed and consult with other staff on related issues and special projects involving QC testing issues and methods. Actively participate in the development and transfer of testing methods from Research & Development or other departments to QC.

• Write and revise test methods, SOP's, Outlines of Production, Special Outlines, test records, and forms and ensure that all documents used in QC comply with internal and external regulatory requirements. Write and review technical reports for submission to USDA or other health authorities.

• Assist the Site Quality Head in the preparation of the annual budget. Prepare documentation for budgeted capital equipment and supplies

• Participate in other special projects or activities as assigned by management.

Other duties may include:

• Strategic Planning intended to develop and execute departmental plans and priorities based on site, regional or company driven goals.

• Support of regulatory inspections and audits.

• Support of validation activities and other associated Quality functions.

Education Minimum Requirements:

• Bachelors of Science degree in Microbiology, Biology, Biochemistry, Chemistry or a related field.

Required Experience and Skills:

• Must demonstrate a thorough understanding of testing procedures and systems used in the QC laboratory.

• Proficiency with USDA testing procedures, supplemental assay methods and 9 CFR regulations.

• Three (3)+ years of supervisory experience within the biologics industry.

• Experience in review/approval of GMP documentation

• Individual must be highly organized and possess good planning skills to handle multiple projects.

• Individual must have good communication skills and ability to interface with all levels of the organization.

• Good technical writing experience

• Excellent computer skills (i.e. Word, Excel, Power Point, Microsoft Office, etc.)

Preferred Experience and Skills:

• Strong knowledge of USDA, GMP, FDA or EMEA regulation regarding vaccine manufacture

• Quality Control, Quality Assurance and/or cGMP experience

• Experience with lean, six sigma or similar

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

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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.

Learn more about your rights, including under California, Colorado and other US State Acts

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".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.

Requisition ID:R329203