Senior Specialist, Quality

Job Description

Position Description

The Senior Quality Specialist, with guidance from the Integrated Product Team (IPT) Quality Operations Leader or E2E Quality Operations Leader, ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace.  The Senior Quality Specialist ensures all necessary documentation (CRs, IQ/OQs, PQs, etc.) is approved, valid, and complies with all Regulatory and our manufacturing division requirements.  This person is responsible for working closely with the various groups within the assigned IPT or E2E in a team environment to enable the timely release of product to the marketplace.

Job Functions

• Manages aspects of the material control and/or release process as it relates to control of material for investigations and risk processing. 
• Responsible for compliance to cGMPs on the shop floor for assigned IPT or E2E. 
• Collaborates with personnel in Operations, Technology, and Planning to resolve issues, support investigation completion and approval, provide recommended production dispositions and corrective actions where appropriate.
• Performs review and approval of GMP documentation including quality notifications, CAPAs and commitments, Change Requests for assigned IPT or E2E (including Packaging Artwork and LIMS changes), qualification documents, Master Batch Records, et al.
• Performs GMP walkthrough inspections within IPT or E2E to ensure compliance with cGMPs and regulatory requirements.
• Supports the preparation of regulatory filings by providing data and review, as required.
• ·Maintains a broad-based knowledge of GMPs, Manufacturing Policies, Guidelines and Procedures, regulatory guidance, evolving regulatory trends, and the working mechanics of our Manufacturing Division.  Provides guidance to Operations and/or Laboratory Operations on quality issues based upon experienced and mature judgment and utilizes strong interpersonal skills to work with a diverse group of personnel in handling non-routine issues. 
• Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
• Represents Quality on assigned project teams and leads those projects relevant to Quality within the IPT or E2E.  Develops/updates systems on the aspects of material control/product release/shop floor compliance/deviation management within the established policies and guidelines.  Supports company strategic, departmental operational excellence and manufacturing regulatory initiatives.  Responsible for acting as the quality representative on capital projects.
• Actively participates in site inspection/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information, and presenting to inspectors on required topics as Quality representative for assigned IPT or E2E.
• Provides training to incoming personnel and ensures compliance with departmental procedures. 

 

Education Minimum Requirement and Experience

• Bachelor’s degree (BA/BS) in Science, Engineering, or related area of study with four (4) years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and regulatory requirements

 

Required Experience and Skills

• Demonstrated analytical, problem-solving and communication (oral/written) skills are required.
• Strong understanding of regulatory requirements and cGMPs
• Demonstrated leadership competence.

 

Preferred Experience and Skills

• Experience with Deviation Management, Change Requests, and/or Customer Complaints is strongly preferred.
• Experience in batch release.
• This role supports our production area therefore on-site representation is normally required.

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

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:

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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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R288309