Specialist, Quality Assurance

Job Description
Our Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in alignment with our high standards of quality. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Our Company will construct 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 capital project to construct the facility, 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 product, drug substance, media preparation, and sterile supply. Position Responsibilities :
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.
Supporting areas such as Design, Commissioning, Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizers, etc.).
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.
Education Minimum Requirement :
Bachelor's and/or Master's (or other advanced) Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline.
Required Experience and Skills: With Bachelor's Degree, at least 3 years of experience in the pharmaceutical industry or highly regulated industry.
With Master's (or other advanced) degree, at least 1 years of experience in the pharmaceutical industry or highly regulated industry.
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.
Schedule: Monday - Friday, 6 AM - 2:30 PM EST. (May include weekends and holidays) Preferred Experience and Skills: 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.
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.
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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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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:
10% Flexible Work Arrangements:
Not Applicable Shift:
1st - Day Valid Driving License:
Yes Hazardous Material(s):
N/A Requisition ID: R281769