Senior Specialist, Quality Assurance

Job Description
Our Company has constructed a new manufacturing facility to significantly expand its production capacity. 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 dedication 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 Senior Specialist will assist with projects into commercial operation. Project activities include the capital project to provide support to 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 the Drug Product area of the business.
Responsibilities

• Reporting to the Quality Assurance Organization, will independently manage project assignments.
• Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System.
• Support and maintain a "Safety First", " Quality Always" environment with participation in Site GEMBAs for Safety and Quality Compliance.
• Focusing on areas such as Process Development and additional Qualification Activities, and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, washer, depyrogenation tunnel, lyophilizer, capper, automated inspection machine, etc.)
• Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, Quality Change Management, PQ, Engineering Batches, PPQ, and other technical / cGMP documents to meet schedule milestones.
• Review and approval of master batch records executed records, technical protocols, investigations, change controls, SOPs, Work Instructions, Job Aids, validation protocols, and technical reports.
• Support Shop Floor Quality Assurance (SFQA) and the Technical Operations Deviation Management groups with event assignments, classifications, investigations, corrective and preventative actions, reviews and approvals through current Quality Systems (e.g., CLUE and SAP).
• Escalate and collaborate quality and compliance issues as needed through established site Tiers.
• Support compliance to Durham Site policies and procedures that promote Permanent Inspection Readiness (PIR).
• Partner with site and above 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 with Right First-Time goals.
• Consults on an as-needed basis with next level manager on more complex decisions.

Minimum Required Education and Experience:

• Bachelor's degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with five (5) years in the pharmaceutical industry or highly regulated industry. OR

• Master's degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with three (3) years in the pharmaceutical industry or highly regulated industry

Required Experience and Skills:

• Minimum two years 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 including technical writing. Ability to manage multiple priorities.
• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

Preferred Experience and Skills:

• GMP quality experience with biological drug product.
• GMP experience with qualification of equipment.
• Strong Background in cGMP document review and approval.
• Strong background in cGMP compliance standards (QMS, EHS, and Site SOPs)
• Independent, self-directed strong skill sets in planning / scheduling, and time management.
• Experience with Quality Risk Management.
• Experience with Quality Change Management.
• Project Management experience in a highly regulated industry
• Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS.
• RCA (Root Cause Analysis) with problem-solving experience utilizing MPS / LSS tools.
• Software Proficiency: Microsoft Excel, Work, PowerPoint, Teams.

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.
Residents of Colorado
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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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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".
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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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
06/29/2024
*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.
Job Posting End Date:06/29/2024
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:R300359