Job DescriptionPosition Description:Specialist, Quality Assurance 2nd ShiftOur Company constructed a new manufacturing facility to significantly expand its production capacity for a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding commitment to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Specialist will support this expansion. Project activities requiring support include the process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product. The focus for the position includes all aspects of Quality oversight for drug substance, media preparation, and sterile supply. The candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operations of pharmaceutical, biologic, and/or vaccine manufacturing facilities. The successful candidate must be able to examine issues from diverse perspectives, provide a hands-on approach to problem solving, and be self-motivated to identify and lead process improvement projects.Position Responsibilities Could Include :
Reporting to the Quality Assurance Organization, will independently manage project assignments.
Ensure individually assigned aspects of the project proceed in compliance with cGMP, regulations, and our Company’s Quality Management System.
Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents to meet schedule milestones.
Provide QA shop floor support on batch review, alarm response, incursion response and deviation management.
Provide QA shop floor support on Aseptic techniques, aseptic observations, cleaning techniques, and gowning observations.
Partner with site functions to solve problems and achieve goals.
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.
Executes critical site review and review of environmental monitoring data.
Perform review of process simulation batch records.
Perform Quality retain sample management activities, if applicable.
Lead Shopfloor audits to identify and address housekeeping and/or compliance gaps.
May approve incidents and investigation related to deviation management.
Assists cross-functional team with executing and approving change controls.
Approve cleaning validation documentation as needed.
May act as a Quality Risk Assessment Lead.
Education Minimum Requirement : High School Diploma or equivalentRequired Experience and Skills: Minimum four (4) years of experience in manufacturing, maintenance, laboratory, military environment, or related industry including two (2) years of experience in an GMP or FDA regulated industry. Schedule: Monday - Friday, 2:00 PM - 10:30 PM EST (will include weekends and holidays to support project work).Preferred Experience and Skills:
At least 1 year of experience in aseptic manufacturing or other clean room environment .
Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.
Effective decision making, problem solving and communication skills. Ability to manage multiple priorities.
Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.
GMP quality experience with biological drug substance or drug product.
GMP experience with qualification of equipment.
Experience with Quality Risk Management.
Project Management experience in a highly regulated industry.
Experience with Kneat, SAP, Veeva and/or GLIMS.
Experience in deviation management with focus on quality review and approval.
Experience in Aseptic processing, aseptic observations, and techniques.
Electronic manufacturing batch records (eMBR) experience.
Demonstrated interpersonal skills including flexibility and collaboration.
Demonstrated analytical aptitude, critical thinking skills, and problem solving.
Demonstrated ability to upskill others.
Demonstrated verbal and written communication skills.
Experience in pharmaceutical related environment.
VETJOBS #EBRG TechnicianDurham #MSJRCurrent Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.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, Monday - 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”.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch 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:Not ApplicableShift:2nd - EveningValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:02/22/2025A 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: R335274