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Job Description

Job Description:

Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed aligned with our high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Assurance Manager will direct QA activities and provide support and expertise to the Millsboro, DE site. Collaborates with Quality Control, Regulatory Affairs, Manufacturing, EHS (Safety), R&D, BTS (Bio-process Technology Support) and ATS (Analytical Technology Support) to ensure site quality systems, processes and projects meet or exceed regulatory and company standards. Collaborates with site leadership on quality standards and release criteria to ensure that all products are pure, safe, potent and efficacious. Manages team members to include coaching on quality principles, inclusive behaviors, and best practices. Interacts with our Company sites for best practice sharing.

The Manager of Quality Assurance at the Millsboro site reports to the Associate Director of Quality. The QA manager will oversee a staff of ~10 employees and is responsible for the execution and oversight of all Quality Assurance activities including but not limited to the following:

+ Prioritizing the schedule of Quality activities in accordance with customer requirements.

+ Performing Quality review, approval, and submission of finished product serials

+ Managing Product Release submission process to USDA CVB.

+ Document Management including Batch Record Review and archiving, SOP Management and review, Test Record review and approval, and Regulatory Communications.

+ Performing GMP walk through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements. Assistance with external audits may also be required.

+ Direct support and management of Regulatory Authority Inspections.

+ Authoring, reviewing and approving revisions to SOPs, technical documents, including risk assessments and investigation reports.

+ Aiding all areas of the site in drafting and review of significant investigations as needed.

+ Performing Quality reviews and approval of new and updated Procedures and Controlled Job Aids.

+ Quality Risk Management oversight.

+ Assisting with annual review of the Site Master Plan.

+ Other duties as required by management.

+ Actively participates in the Tier process and uses this forum to escalate concerns and best practices.

Education Minimum Requirement:

+ Associate's degree in a scientific or analytical field, with (8) years’ relevant experience. Candidates with degrees in other fields will be considered if accompanied by significant relevant experience. **OR**

+ Bachelor’s degree in scientific or analytical field, with five (5) years’ relevant experience. **OR**

+ Master’s degree in scientific or analytical field, with three (3) years relevant experience.

Required Experience and Skills:

+ Minimum of Five (5) years of experience in Biological operations, technical services and/or Quality operations with experience understanding the quality function.

+ A minimum of one (1) year of experience in a leadership role (manager, supervisor or lead position).

+ Knowledge of aseptic processing and sterility assurance

+ Proven problem-solving skills

Preferred Experience and Skills:

+ Experience in Quality Control or Quality Assurance

+ Familiar with USDA 9 CFR regulations.

+ Animal Vaccine experience

+ Prior project management experience

Required Skills:

Analytical Testing, Analytical Testing, Aseptic Processing, Biomanufacturing, Change Management, Configuration Management (CM), Cross-Functional Teamwork, Detail-Oriented, Deviation Investigations, Document Management, GMP Compliance, Health and Safety, Inspection Systems, IS Audit, Management Process, Occupational Safety and Health, Packaging Science, Prioritization, Process Quality Control, Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Assurance Processes, Quality Control Management, Quality Improvement Programs, Quality Management Systems (QMS) {+ 4 more}

Preferred Skills:

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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 salary range for this role is

$96,200.00 - $151,400.00

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.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

**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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

01/21/2026

*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:** R379079