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Quality Assurance Specialist, Vaccines

4 months ago

Wilson, North Carolina, United States Merck Full time

Job Description

Under the general direction of the Associate Director, Wilson Quality Operations, the Specialist is primarily responsible for support of Quality Assurance activities within the Vaccines facility at the Wilson, NC Site.

The Specialist will be responsible for quality activities to support commissioning, start up, licensure, and continuing operations for the Vaccines facility at the Wilson site. The position is responsible for comprehensive oversight / management associated with the applicable Quality systems ensuring that business objectives are met within budgetary constraints and that a high standard for Quality and EHS compliance is maintained. The position will also be expected to promote behaviors of continuous improvement and ensure that the Quality team maintains an inclusive culture that supports positive employee relations. Specific leadership principles expected of the Specialist include:

  • Contributes to the performance and results of the Quality department and Integrated Process Team (IPT).
  • Adapts, plans, and prioritizes to address operational challenges.
  • Executes activities to ensure that all safety and compliance regulations are adhered to and enhanced, where applicable.
  • Executes activities to meet or exceed customer expectations.
  • Anticipates and interprets customer needs to identify solutions.
  • Provides technical guidance to colleagues and receives guidance from manager.

In addition, this position will be responsible for the following (but not limited to) activities: review and approval of validation / qualification documentation, batch record review, support for internal/external audits, inspection readiness management, execution of complaint investigations, approve investigations, Annual Product Reviews, regulatory document reviews, process change request activities, SOP development and review, execution of environmental sampling, and other Quality Assurance related functions.

Delivery

  • Performs, interprets, reviews, and approves equipment/process validation/qualification activities. Provides review and approval of change control documents.
  • Performs and coordinates in-depth system based, process and pre-PAI audits as it relates to compliance concerns and communicates and manages any resulting corrective action plan.
  • Performs incoming material, bulk, and finished product release activities to include CBER Release requirements. Accepts delegated authority for review and release of materials / documents designated for domestic and international distribution as required.
  • Manages, tracks, and trends Vendor Quality Reports, and examines report responses and participates with corrective actions.
  • Responsible for defect resolution and the control of material throughout the plant. Participated in the completion of significant deviations, field alerts, BPDR's and investigational activities which span multiple sites, divisions and competencies. Able to interpret policies, regulations, etc. to determine defect classification and appropriate resolution activities and mentor others on these decisions.
  • Completes routine complaint, stability, vendor and packaging investigations and recommends disposition of affected material. Possesses excellent technical writing skills and drives peers and customers to provide robust investigations. Challenges technical support and production groups to ensure robust root cause analysis and identification of corrective actions. Monitors trends and recommends corrective actions to cease continued performance issues. Able to present data to others outside of working group to gain consensus on appropriate path forward.
  • Completes Annual Product Reviews and retrieves approval signatures. Completes analysis of product performance trends.
  • Provides Quality Assurance review and approval of all GMP-related SOPs. Develops programs / procedures to improve compliance status of Wilson operations.
  • Ensures that all SOPs and documentation associated with the Quality systems are maintained and adhered to.
  • Supports the environmental monitoring program as needed.
  • Performs a variety of regulatory document reviews.
  • Manages, tracks and trends a variety of compliance performance indicators, recommends appropriate actions to drive compliance improvement.
  • Resolve and escalate issues impacting supply within the daily, weekly, and monthly IPT management processes.
  • Performs other duties as assigned.

Leadership Principles

  • Ensure a culture of inclusion and consistency is maintained, supporting positive employee relations within the Quality team and site.
  • Actively participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables.
  • Responsible for knowledge of cGMP and safety requirements.
  • Routinely makes decisions to meet performance objectives using cGMP and safety knowledge as a guide.
  • Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence.
  • Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes. Reports to the Associate Director for general advice and instruction, but normally handles routine matters independently, consulting on major problems only.
  • Applies leadership principles to all actions.
  • Maintains 5S organization and identifies improvement opportunities.
  • Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents.
  • Performs duties and responsibilities of the Associate Director in his/her absence, as required.

Cost

  • Ensure that activities are carried out in accordance with departmental budget.
  • Recognize and implement opportunities for efficiency and financial savings.

Continuous Improvement

  • Drives continuous improvement (business and compliance excellence) opportunities through the use of lean six sigma methodology and identification of improvement opportunities. Drives collaboration and engagement across functions both internally and externally to implement improvement. Participates and leads divisional teams focused on improvement.
  • Partner with Technology, Operations, and other groups to identify and implement continuous improvement initiatives that support the strategic goals of the IPT.
  • Actively participates in Plant / Quality committees and works with other Quality groups, Planning, Manufacturing, Maintenance, and others as required to resolve problems, and satisfy quality and production needs.
  • Identify opportunities to modify standard work, procedures, or equipment to optimize efficiency.

Compliance

  • Ensure that Quality activities are executed in compliance with Safety, Environmental, cGMP, and Labor regulations.
  • Investigate, determine root cause, and implement robust CAPAs for any compliance discrepancies noted during day to day activities and/or audits. Escalate as per IPT management processes.
  • Facilitates / participates in internal / external and joint venture GMP audits. Participates / facilitates in audits of vendors, tollers, or other sites / operations. Facilitates / participates in regulatory inspections with the ability to independently manage all aspects of inspection facilitation. Leads compilation of agency responses.
  • Tracks and monitors timely completion of regulatory commitments and maintains an evidence file for completed items.
  • Monitors / trends regulatory inspection activity at MMD sites and other appropriate pharmaceutical manufacturers by networking both inside and outside our company, Inc. and initiates formal reviews of such activity, where required, through the Regulatory Surveillance Program.
  • Leads implementation of new programs / regulations / divisional processes at the site.
  • Participates in policy development activity both locally and with MMD compliance experts externally. Interprets Quality policies, GMPs and other agency regulations for application to Wilson Operations.
  • Participates in the generation and interpretation of Quality Manual documents.
  • The incumbent must remain abreast of current technical, industry, and management literature.
  • Manages and maintains the Site Master File

Education Minimum Requirement:

  • B.A./B.S. degree (preferably in Science or Engineering)

Required Experience and Skills:

  • Minimum of 3 years of experience in pharmaceutical operations, technical services, and/or quality operations with at least 1 year in a quality function
  • Strong leadership and communication skills
  • Demonstrated ability to work independently as a team member
  • Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine / pharmaceutical industry
  • Proficiency using standard software including MS Excel, MS Word, etc.

Preferred Experience and Skills:

  • SAP / MES working knowledge
  • Experience with aseptic filling and packaging
  • Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First Time methodologies
  • Familiarity with Change Execution Management and Behavioral Coaching / Consequence Management tools
  • Experience supporting regulatory inspections including FDA
  • Strong written and verbal communication skills including technical writing experience with investigations, change requests, standard operating procedures, protocols, etc.

Shift: 12 hour day shift

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.

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

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/29/2024

*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:05/29/2024

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:R293456