Senior Specialist, Quality Control

Job Description

The Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing the review of microbiological, chemical, and analytical data. This role requires close collaboration with various teams including Production, Quality Assurance, Validation and Facilities, as well as external resources, when necessary, to support manufacturing processes.

Responsibilities of the Quality Control Senior Specialist include leading routine testing of products, driving continuous process improvements, troubleshooting issues, and providing support for investigational testing. Additionally, the role entails writing Standard Operating Procedures (SOPs) to maintain consistent and high-quality laboratory practices.

Responsibilities

• Reviews and authorizes microbiological testing data
• Reviews and authorizes environmental monitoring data to include active air and surface sampling and water sampling
• Performs Critical Site Review (CSR) for production processes
• Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects
• Initiate and lead Change Requests utilizing IPI
• Participate in Quality Risk Assessments
• Authors standard operating procedures (SOPs)
• Collaborate with internal customers and vendors to identify, evaluate and implement new analytical technologies that expand site capabilities
• Apply project management concepts and techniques as they relate to analytical testing, regulatory requirements for assay development/validation, project timelines and budgeting
• Build knowledge of the company, processes, and internal/external customers
• Build and maintain strong relationships with site leadership, stakeholders, and customers
• Build relationships to work in a highly functioning diverse team environment
• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
• Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing
• Capability to function effectively within an automated/electronic laboratory environment

This position is based on-site with a schedule of Mon-Fri, 8am-5pm with occasional weekend work.

Education Minimum Requirement and Experience:

• Bachelor's degree of science (BS) in science, Engineering, or related areas of study with five (5) years' work experience in a pharmaceutical, manufacturing, laboratory, or related environment. OR
• Master's degree of science (MS) in science, Engineering, or related areas of study with three (3) years' work experience in a pharmaceutical, manufacturing, laboratory, or related environment.

Required Experience and Skills:

• Fully trained in GMP data review/authorization.
• Experience and working knowledge of IPI Change Request system and process.
• Strong verbal and written communication skills.
• Supports site, divisional and Quality initiatives.
• Reviews and approves SOPs for Quality and supporting departments.
• Experience with SAP and LIMS.
• BCG Production Medical Clearance

Preferred Experience and Skills:

• Experience with eLogs and Trackwise
• Ability to gown aseptically
• Experience with aseptic processing operations such as cell culture, filling, and lyophilization

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

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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:

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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.

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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, generally Tuesday, Wednesday and either Monday or 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".

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.

Job Posting End Date:05/26/2024

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:R296839