Job Description
Senior Specialist, Quality Assurance The Quality Assurance team ensures that every material used in our products is manufactured, tested, packaged, stored, and distributed according to high standards of quality and in compliance with all regulatory requirements. The Senior Specialist, Quality Assurance will support ongoing efforts to supply the market by providing quality oversight for Validation, Plant Engineering, and Deviation Management activities related to drug substance and drug product manufacturing.
Position Responsibilities Reporting to the Associate Director, Technical QA, the Senior Specialist, QA Technical will independently manage assignments related to compliance with cGMP regulations and our Company's Quality Management System. Responsibilities include:
- Supporting Validation, (Re)qualification, Deviation Management, and compliance activities of equipment used in manufacturing areas.
- Reviewing and approving technical protocols, investigations, change controls, SOPs, validation protocols, and technical reports related to the assigned area.
- Partnering with site functions to solve problems and achieve goals.
- Collaborating closely with the Technical Operations team to track and complete assignments related to equipment validation/qualification and deviations.
- Making decisions guided by policies and procedures that impact the team's ability to meet performance objectives.
- Escalating and consulting with the next level manager on more complex decisions as needed.
Position Qualifications Education Minimum Requirement - Bachelor's Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or a related life science or engineering discipline.
Required Experience and Skills - With a Bachelor's Degree: At least 5 years of experience in the pharmaceutical industry or a different highly regulated industry.
- With a Master's (or other advanced) degree: At least 3 years of experience in the pharmaceutical industry or a different highly regulated industry.
- At least 1 year of experience in aseptic manufacturing or another cleanroom environment.
- Strong contemporary knowledge of relevant current Good Manufacturing Practices (cGMPs), regulations, and current industry trends.
- Effective decision-making, problem-solving, and communication skills.
- Ability to manage multiple priorities.
- Demonstrated ability to work in fast-paced, complex environments and escalate issues appropriately.
- Experience with the development, review, and approval of validation/qualification documents and investigations related to pharmaceutical and biotechnology manufacturing equipment, facilities, and utilities.
Preferred Experience and Skills - Prior experience in change control and deviation management.
- GMP quality experience with biological drug substances or drug products.
- GMP experience with validation/qualification of equipment.
- Experience with Quality Risk Management.
- Project management experience in a highly regulated industry.
- Familiarity with Kneat, SAP, Veeva, MEDS, and GLIMS.
- Experience in deviation management with a focus on quality review and approval.
- Experience in aseptic processing, aseptic observations, and techniques.
- Participation in regulatory inspections.
- Conversant with all domestic and foreign regulations and compendia governing plant operations.
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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.
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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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
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 salary range for this role is
$104,200.00 - $163,900.00
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 .
You can apply for this role through (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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable
Shift: Valid Driving License: Hazardous Material(s): Required Skills: Adaptability, Adaptability, Aseptic Operations, Biochemistry, Biological Engineering, Biological Sciences, Biomedical Engineering, cGMP Compliance, Data Analysis, Deviation Management, Environmental Monitoring, GMP Compliance, Life Science, Management Process, Motivation Management, Pharmaceutical Management, Policy Procedures, Professional Integrity, Project Management, Quality Auditing, Quality Inspections, Raw Material Testing, Regulatory Compliance, Regulatory Inspections, Stability Studies {+ 3 more}
Preferred Skills: Job Posting End Date: 07/9/2025
*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: R354827
Job Tags
Holiday work, Full time, For contractors, Local area, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,