Specialist, Quality

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Specialist (QS) provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. Execution of the activities and responsibilities related to this position are designed to further develop the knowledge and skill foundation required to advance to other Quality-based functions within the organization. The Quality Specialist, with guidance from the IPT Quality Lead, ensures product/process quality, performs activities to facilitate the release of product to the marketplace, and ensures proper control of material and provides Quality support directly to the production floor, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, and effective investigation of atypical events.

Additionally, the QS spends significant time on the shop floor to partner with Operations and Technology to enable right first time production, to learn the manufacturing process, and to ensure compliance with cGMPs and regulatory requirements. The QS performs document/logbook audits for accuracy and completeness and will also work closely with the assigned organization in a team environment to ensure timely review documentation and that is done right-first-time. The QS is knowledgeable in federal and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance, and will train on and gain competency in activities to ensure quality and compliance of product manufactured by the functional area.

Primary Responsibilities

• Performs 100% audit of process documents/log books to ensure completeness and accuracy for assigned functional area and maintains any tracking databases and logs associated with this review

• Provides coaching and mentoring of Operations personnel with regards to documentation completion

• Coordinates with Operations to discuss, resolve, and eliminate documentation observations

• Performs GMP walk through inspections of assigned departments within organizations to ensure compliance with cGMPs and regulatory requirements

• Ensures proper identification of release status and control of materials through maintenance of quarantines in the SAP system and through physical tagging of material as required

• Performs Quality review/approval of new and updated SOPs and CJAs

• Assists with training of incoming personnel and ensures compliance with departmental procedures

• Actively participates in the departmental communication process and uses this forum to escalate concerns and best practices

• Collaborates with members from other support groups within the functional organization, such as Operations, Technology, and Scheduling, in the identification and implementation of continuous improvement initiatives and action plans

• Works with necessary groups within the functional area to resolve outstanding issues with process documents/log books, GMP walk through inspection observations, and quarantine management

• Cross trains to support other functional quality areas including but not limited to deviation management, environmental monitoring investigations, and inspection support

• Completes training and is qualified to review qualification documents, change requests, and atypical event investigations

• Prioritizes review of process documents/log books in order to maximize cycle-time efficiency

• Performs SAP transactions required to document Batch Record and Critical Site review

Education Minimum Requirement

• Bachelor degree | Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience

Required Experience and Skills

• At least one year of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations

• Evidence of leadership skills coupled with good verbal and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills

• Effectiveness and creativity in approaching and solving technical problems

• Attention to detail, flexibility and an awareness of production and attendant quality control problems

• Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area

• Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, Outlook, and/or MS Access)

• Flexibility to support off-shift or weekend schedules, if necessary

Preferred Experience and Skills

• Familiarity with vaccine and/or pharmaceutical processing

• Manufacturing batch records is a strongly preferred skill necessary for success in this position; prior batch record experience is a plus

• Quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is a strong plus

• Aseptic gowning

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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Pay Transparency Nondiscrimination

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:

Relocation:

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Flexible Work Arrangements:

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• 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:R326100