Primary Responsibilities:

The Quality Senior Specialist will be responsible for comprehensive management of all activities required to successfully support Process Performance Qualification (PPQ) and routine manufacturing to include the following:

• Ability to work independently and as a member of a team.
• Manages individual contributors (professional employees), as applicable.
• Contributes to the performance and results of the expansion project.
• Adapts plans and priorities to address resource and operational challenges.
• Decisions are guided by policies, procedures and/or business plans.
• Provides technical guidance to employees, colleagues, or clients.
• Anticipates and interprets client and/or customer needs to identify solutions.
• Ability to provide off shift and weekend support during critical processing and manufacturing.
• Responsible for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.
• Responsible for establishing processes that ensure required safety guidelines are followed.
• Review and approve qualification/validation documents for equipment and process (i.e., IQ/OQ/PQ).
• Review and approve Performance Qualification documents pertaining to environmental monitoring and process qualification.
• Provides Quality input, direction, and approval of Quality Notifications (QNs) and Change Requests (CRs). Author, review, and approve SOPs.
• Assume project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality management.
• Train employees on new or revised processes or procedures.
• Review and approve BOM changes and Master Batch Records.
• Review and approve Operations, Technology, or Automation protocols.
• Leads or actively participates in project suite teams, as required.
• Direct support of regulatory inspections and audits.
• Direct support of validation activities and all other associated Quality functions.
• Other duties as requested by Management.
• Independently supports resolution of technical and operational problems through collaboration with peers.
• Applies appropriate risk management while adhering to cGMP requirements.
• Makes decisions guided by policies and procedures that impact the team's ability to meet performance objectives.
• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.

Minimum Education Requirement and Experience:

• Bachelor's degree (BA/BS) in Biology, Biochemistry, Chemistry, or other relevant discipline with a minimum of five (5) years' experience supporting the pharmaceutical manufacturing industry, specifically in pharmaceutical operations, technical operations, validation and/or process Quality Assurance.

Required Experience and Skills:

• Previous investigation and CAPA experience, Batch Record Review, Validation IQ, OQ, PQ, Change Control.
• Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.
• Is expected to possess 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:

• Quality Technical experience
• Electronic Batch Records (MES)
• cGMP experience in a sterile, bulk or finished pharmaceutical environment.
• Product, Raw Materials and Components Release
• Experience with SAP or MRP/ERP systems
• Experience with SAP, or GLIMS
• Flexibility to support on-call and hyper-care activities.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #EBRG VETJOBS

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

EEOC GINA Supplement

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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".

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:
25%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
10/24/2024
*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:R316776