Associate Specialist, Environmental Monitoring job in Durham
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North Carolina (NC),
Durham
| Job Code: | MERCUSR292121ENUS |
| Employer: | Merck & Co. |
| Category: | Manufacturing |
| Job Type: | Full Time |
| Location | |
| Country: | United States |
| State: | North Carolina (NC) |
| City: | Durham |
| Post Date: | 05/04/2024 |
| Description | |
|
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.
BUSINESS EXPERTISE:
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:
PROBLEM SOLVING:
INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:
IMPACT :
PROJECT MANAGEMENT:
RESOURCE MANAGEMENT:
QUALIFICATIONS : Required:
Preferred:
PHYSICAL REQUIREMENTS:
WORKING RELATIONSHIPS:
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. - 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. 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: 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 | |
ref: (MERCUSR292121ENUS) 13 days ago
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