Vacancy expired!
Job DescriptionThe Quality Operations Laboratory Senior Specialist is accountable to support day-to-day operation of the Potency laboratory. The successful candidate will support testing, provide troubleshooting to test method and equipment related issues.The Senior Specialist 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 understand of Labware LIMS, handle Quality Notification, Change Controls, authoring SOPs and protocols and provide audit support.Responsibilities:
Schedule daily testing of laboratory samples based on internal metrics and production needs
Serve as a Subject Matter Expert (SME) for internal and regulatory inspections
Provides active support during audits and inspections (regulatory, internal, safety)
Participate in routine audits of Quality Operations laboratory to ensure compliance and inspection readiness
Train and mentor laboratory analysts on test methods, techniques, and good documentation practices
Author and implement test method qualifications and final reports for assays
Lead and support troubleshooting OOS and invalid assays. Provide scientific guidance for investigation
Authors standard operating procedures (SOPs) for the performance of laboratory methods
Trouble-shoots equipment issues
Collaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirements
Supports our Manufacturing Division divisional and Quality initiatives
Bench work support
Minimum Education Requirements and Experience:
Bachelor of Science Degree (BS) in Chemical Engineering, or Scientific Field preferably biology, biochemistry, or life sciences and five (5) years laboratory testing; OR
Master of Science Degree (MS) in Chemical Engineering, or Scientific Field preferably biology, biochemistry, or life sciences and three (3) years laboratory testing
Required Experience and Skills:
A minimum of (3) years in QC laboratory in GMP settings
Effective and principled technical writing skills with high attention to detail
Bioanalytical methods
Various laboratory instrumentation
Work independently and within a team environment
Deviation support, change controls or method validation
Principled communication skills
Proven track record of successfully planning, executing, and troubleshooting projects and experiments
Proficient with Microsoft Office: Word, Excel, PowerPoint
Preferred Experience and Skills:
Mammalian cell culture (aseptic technique) | BSL-2 organisms
Vaccine potency testing
Trained in root cause analysis methodology
Analytical method transfer
Knowledge of method development and validation for use within the QC laboratory
Equipment Validation
Working knowledge of international regulatory guidelines, such as ICH, EP, JP
Statistical data analysis with JMP or other software
NOTICE FOR INTERNAL APPLICANTSIn 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.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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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 (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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 CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:On-SiteShift:1st - DayValid Driving License:NoHazardous Material(s):n/aRequisition ID: R259198
