Sr. Specialist, Quality
Sr. Specialist, Quality
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Job Description
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 Companys 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 teams ability to meet performance objectives.
Escalating and consulting with the next level manager on more complex decisions as needed.
Position Qualifications
Education Minimum Requirement
Bachelors 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 Bachelors Degree: At least 5 years of experience in the pharmaceutical industry or a different highly regulated industry.
With a Masters (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 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:
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 anothers 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 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
$104200.00 - $163900.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
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 morePreferred Skills:
Job Posting End Date:
07/9/2025*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:
Senior IC
Employment Type
Full-Time
