Merck & Co Hiring for Specialist, Quality job in Durham Full Time

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.

Position Description: Specialist, Quality

Primary Responsibilities

General Profile

• Ability to work independently and as a member of a team.
• Contributes to the performance and results of the Sample Control team.
• Adapts plans and priorities to address resource and operational challenges.
• Decisions are guided by policies, procedures and/or business plans.
• Requires knowledge and experience in own discipline; still acquiring higher-level knowledge and skills.
• Builds knowledge of the company, processes and clients and/or customers
• Analyzes possible solutions using standard procedures.
• -Receives a moderate level of guidance and direction.
• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.

Functional Expertise

• Perform annual visual examinations on vaccine filled vials for the retention program.
• Sample receipt, discard, and management of samples for the retention program.
• Basic conceptual knowledge and practices associated with document review as it relates to the release of bulk, raw materials, and general incoming components.
• Perform necessary SAP transactions to indicate task completions or stock status updates to support batch disposition decisions.
• Provide support to Vendor Quality Management system.
• Lead Supplier Qualification and Reduced Testing initiatives.
• Comprehends and applies regulatory and compliance requirements relative to their role.
• Understands the fundamental business drivers for the company and uses this knowledge in own work.
• Basic conceptual knowledge and practices associated with inspection of incoming components and materials utilized in manufacturing in accordance with component specifications and procedures.
• Accountable for utilizing component specifications to perform visual inspections, dimensional verifications, document reviews, and other tasks related to quality control to ensure materials meet quality standards as applicable.
• Document results of inspection onto inspection record and global laboratory information system
• Must exhibit meticulous attention to detail and possess good organizational skills.
• Assist in investigations, which includes interactions with vendors or our Company internal teams to resolve issues associated with incoming components.
• Development of metrics and process improvements for disposition prioritization and lead time reduction
• Participate in process improvement or learning events, as guided or approved by Quality management.
• Author, review, and approve Standard Operating Procedures (SOPs)
• Participate in GEMBAs and safety walkthroughs.
• Direct support of regulatory inspections and audits, as requested.
• Other duties as requested by management.
• Responds to standard requests from clients and/or customers.
• Explains information and persuades others in straightforward situations.

Problem Solving

• Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures.
• Supports resolution of technical and operational problems through collaboration with peers
• Applies appropriate risk management while adhering to Current Good Manufacturing Practice (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 interrelated processes.

Physical Requirements

• Ability to sit, stand and move within workspace for extended period.
• Ability to lift fifty (50) pounds.
• Ability to work standing in a laboratory environment for extended periods.
• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling.
• Ability to work in cold storage environments.
• Ability to work with common warehouse equipment such as lift trucks.

Position Qualifications:

Education Minimum Requirements

• Bachelors in Biology, Chemistry, or other relevant discipline

Required Experience and Skills:

• cGMP experience within a pharmaceutical operation complying with both domestic and international regulations.
• Minimum of (2) years experience in pharmaceutical operations, technical services, and/or quality operations with at least one year in a quality function

Preferred Experience and Skills:

• Quality Control and/or Quality Assurance experience-TrackWise, or Global Laboratory Information Management System
• Prior experience inspecting and releasing incoming components.
• Prior experience with sample management
• Experience with SAP, Microsoft Office Suite

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. #ERBG VETJOBS

Residents of Colorado

Click here to request this role’s pay range.

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:

EEOC Know Your Rights

EEOC GINA Supplement•

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, 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:
No Travel Required

Flexible Work Arrangements:
Remote

Shift:
1st – Day

Valid Driving License:
No

Hazardous Material(s):
Yes

Requisition ID:R286705