Sr. Spclst, Quality Assurance
Sr. Spclst, Quality Assurance
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Description
Primary Responsibilities:
Support the company-Durham site and Quality organization by performing tasks associated with the sites goals and initiatives as they relate to batch release and Quality requirements and standards. This involves the items as listed below but is not limited to the following:
Product release of batches for a company-Durham Facility.
Completion of tasks required to release batches such as DOM/SLED Review QN and CR review testing review market restrictions review and CBER submissions.
Create batch specific documentation such as Health Authority monitoring reports or release-specific shipping documents and prepare packaging or distribution requested batch certificates.
Interface withtechnical other quality tiers release personnelplanning warehouse QPs and problem-solving collaborative meeting groups to support release on time release group needs.
Author review and approve local release SOPs assist with providing product related information to support Change Requests and complete change control release tasks.
Serve as release SME (Subject Matter Expert) to support internal and regulatory audits.
Support and lead department related initiatives associated with KPIs (Key Performance Indicators) process improvements and other goal-driven directives own project management opportunities by leading and participating in process improvement learning events and/or business support initiatives as guided or approved by Quality management
Consults on an as-needed basis with next-level manager on more complex release decisions and/or issues that impact other units with inter-related processes.
Other duties as requested by Management.
Minimum Education Requirement and Experience:
Bachelors degree (BA/BS) in Biology Biochemistry Chemistry Engineering or other relevant discipline with a minimum of four (4) years experience supporting the Biotech/pharmaceutical manufacturing industry specifically in operations technical operations validation and/or process Quality Assurance.
Required Experience and Skills:
Ability to quickly learn new digital systems and software versions.
Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.
A high degree of problem-solving ability.
Must have demonstrated ability to independently manage multiple high level/ priority projects ensuring timely completion.
Preferred Experience and Skills:
cGMP experience with sterile bulk or finished pharmaceutical/biotech manufacturing environments.
Experience with release or disposition of Product Raw Materials and Components Release
Experience that include a variety of deviation/complaints change control release regulatory document control master data management laboratory or manufacturing oversight experience. Not just one area.
Experience with SAP MRP/ERP systems and/or GLIMS
Flexibility to support on-call off shift and hyper-care related activities.
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:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Adaptability Adaptability Batch Record Review Batch Releases Biological Sciences Business Initiatives cGMP Regulations Change Management Chemical Biology Deviation Management Good Automated Manufacturing Practice (GAMP) Immunochemistry Management Process Manufacturing Environments Manufacturing Quality Control Pharmaceutical Manufacturing Pharmaceutical Quality Assurance Process Improvements Product Disposition Production Operations Quality Assurance (QA) Quality Auditing Quality Management Standards Quality Standards Regulatory Compliance 5 morePreferred Skills:
Job Posting End Date:
06/6/2025*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
