Job Description
We are seeking a Growth and Improvement minded Quality Control Laboratory Associate Specialist that can help drive our Strategic Operating Priorities.
- Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
- Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
- Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
- Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
- Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us
Summary, Focus and Purpose
Our Company is expanding its global vaccine production by adding an E2E manufacturing and laboratory in a new facility located in the Durham, NC campus. The new facility will be used to produce the bulk active ingredient, finished product and support laboratory testing for vaccines.
The Quality Control Laboratory Associate Specialist participates on a team of analysts in the method transfer, validation, and routine testing of the vaccine product. Initially the position will focus on microbiology, biological and biochemical assay validation and GMP laboratory readiness in preparation for commercial testing. At the completion of assay qualifications the Associate Specialist will execute routine testing of new and/or existing products, laboratory media preparation, continuing process improvements, troubleshooting, writing SOPs, and investigational testing support. The position will be responsible for testing in new and existing laboratories using principles of Company Production Systems, Lean Laboratories and GMP requirements. Scope of work may also include environmental monitoring of utilities and classified rooms to support new utility and facility qualifications.
Key Functions
General
- Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
- 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 will be located at the Durham, NC site. Short periods of travel may be required as needed for training.
Business and Functional Expertise
- Understands the fundamental business drivers for the company and uses this knowledge in own work
- Understands and applies regulatory/compliance requirements relative to their role
- Influence, motivate, and energize individuals at all levels in the organization
- Responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing
- Microbiology, virology, and/or biochemical assay routine testing and method transfer
- Environmental monitoring of utilities and classified rooms/spaces to support new utility and facility qualifications
- Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods
- Trouble-shoot analytical process and equipment issues
- Sample management
- Planning and test method execution to meet established delivery timelines
- Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning
- Preparation of laboratory media
- Training of laboratory personnel in methods/procedures
- Review of laboratory generated data and results
- Provide active support during audits and inspections (regulatory, internal, safety)
- Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations
- Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements
- Influence, motivate, and energize individuals at all levels in the organization
- Support Manufacturing Division and Quality initiatives
- Additional project and routine testing support as required by vaccine analytical testing requirements
- Other duties as requested by management to support effective laboratory operations and performance metrics
Problem Solving | Resolution
- Identifies and solves a range of problems in straight forward situations | Analyzes possible solutions and assesses each using standard procedures
Internal & External Client/Customer Focus
- Responds to standard requests from internal and external customers
Impact
- Errors on the job may cause time delays and impact the work of others in own work group or potentially impact product disposition
- Influence and Decision Making: Represents Quality in the laboratory to influence cGMP compliance and ensure product quality | Explains information and persuades others in straightforward situations | Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines
- Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality
Project & Resource Management
- Accountable for quality and/or technical contribution to project team or sub-team
- Support project team initiatives to ensure timelines are met and laboratories are prepared for routine product testing
- Aware of costs and assists in controlling costs related to own work
Education
- Bachelor Science Degree
Required Experience | Skills | Knowledge
- One year laboratory experience
- Experience authoring technical documents supporting regulatory filings (IND,BLA)
- Principled verbal and written communications
- Aseptic manipulations
- Exceptional pipetting techniques
- Technical writing skills
- Implementation and trouble-shooting of cell based and other microbiological/biological assays
- Previous GMP-laboratory experience
- Schedule: Monday - Friday, 2nd shift (May include weekend and holidays depending on the need)
Preferred Experience | Skills | Knowledge
- Master degree in Biological Sciences with (1) year laboratory experience
- Responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,).
- Knowledge of CFR, EudraLex, and Compendia testing specific to the pharmaceutical industry
- Media and/or agar formulation
- Biological assay testing in viability/potency
- Regulatory agency audits and/or regulatory filings
- Authoring Standard Operating Procedures
- Training of personnel
- New assay development, validation and/or technology transfer
Physical Characteristics
- Sit, stand and move within work space for extended periods
- Work standing in a laboratory environment for extended periods
- Complete repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling
- Ability to travel
Professional Relationships
- Reports to Quality Manager
- Interacts with employees within own department
- Frequent interaction with employees from other departments and across sites
- Interacts with representatives from regulatory agencies and external suppliers
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. VETJOBS #EBRG
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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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:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
2nd - Evening
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
05/15/2024
*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.
Job Posting End Date:05/15/2024
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:R283451
