Associate Specialist, Environmental Monitoring

Job Description
Our Company is expanding its global Bacillus Calmette Guerin (BCG) vaccine production by adding an end-to-end laboratory capability located in the Durham, NC campus. The new facility will be used to produce the bulk active ingredient, finished product, and laboratory testing for the BCG vaccine.
The Associate Specialist participates in a team of analysts in the development, validation, and routine testing for the BCG Product. The position will focus on environmental monitoring, aseptic process simulation and support testing readiness in preparation for commercial production.- The selected candidate will participate in equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Associate Specialist performs laboratory testing on a variety of product samples and media. The selected candidate will also be expected to review and authorize testing results, collaborate in day-to-day lab scheduling, provide leadership in lean lab initiatives, have a strong understanding of Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support. 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 laboratory testing start-up, regulatory requirements for new 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 will be located at the Durham, NC site.- Short periods of travel may be required as needed for training.-
BUSINESS EXPERTISE:
Understands the fundamental business drivers for the company; 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
FUNCTIONAL EXPERTISE:
The Specialist, Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product activities to include the following:
Sampling of clean utilities including but not limited to compressed gas and water for injection.
Environmental monitoring of production and support areas, including sampling, processing of samples, and reporting results.
Participating in Environmental Monitoring Performance Qualification activities.
Microbiological testing in support of production media.
Participating in aseptic process simulations, including sampling, testing of simulation units, and reporting of data.
Schedule daily testing of laboratory samples based on internal metrics and production needs.
Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods
Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Corrective/Preventative Actions
Execute test method qualification
Trouble-shoot equipment issues as needed
Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning
Train and mentor laboratory analysts on test methods, techniques, and good documentation practices.
Review of laboratory generated data and results
Authorizing and approving of samples
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 our Manufacturing Division Divisional and Quality initiatives
Additional project and routine testing support as required
Other duties as requested by management to support effective laboratory operations and performance metrics
PROBLEM SOLVING:
Identifies and solves a range of problems in straight forward situations; analyzes possible solutions and assesses each using standard procedures
INTERNAL CLIENT/EXTERNAL 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:
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 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
RESOURCE MANAGEMENT:
Aware of costs and assists in controlling costs related to own work
QUALIFICATIONS :
Required:
B.S. in Biological Sciences, with minimum of 1 year of laboratory experience
Experience with aseptic manipulations
Previous GMP-laboratory experience
Work independently and within a team environment
Preferred:
Experience with environmental monitoring activities
Experience in sampling of clean utilities, including but not limited to compressed gases and water.
Good technical writing skills and high attention to detail.
Experience with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,).
Experience authoring technical documents supporting regulatory filings (IND,BLA)
Experience with assay development, validation, or technical transfers
Equipment Validation
Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry
Experience in regulatory agency audits and/or regulatory filings
Experience in technical writing, including Standard Operating Procedures, laboratory investigations, and method transfer/qualification reports
Experience in training of personnel
PHYSICAL REQUIREMENTS:
Ability to sit, stand and move within work space for extended periods
Ability to work standing in a laboratory or production environment for extended periods
Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling
Ability to travel
WORKING RELATIONSHIPS:
Reports to Microbiology Manager
Interacts with employees within own department
Frequent interaction with employees from other departments and across our Company sites
Interacts with representatives from regulatory agencies
Interacts with external suppliers
Note:--- This description is not intended to be all-inclusive or a limitation of the duties of the Job.- It is intended to describe the general nature of the job that may include other duties as assumed or assigned.- 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.
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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 separationpackage, 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.
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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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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:
1st - Day Valid Driving License:
No Hazardous Material(s):
N/A Job Posting End Date: 05/11/2024
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: R292121