3rd Shift, QA Specialist

Merck•Wilson, NC

About The Position

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Under the general direction of the Director, Wilson Quality Operations, the Specialist is primarily responsible for supporting Third (3rd) shift Quality Assurance activities within the RotaTeq® POD facility at the Wilson, NC Site. This position will be a member of the Quality team within the RotaTeq® Integrated Process Team (IPT). The Specialist will be responsible for quality activities to support commissioning, start up, licensure, and continuing operations for the RotaTeq® POD 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 (aligned with MPS principles) and ensure that the Quality team maintains an inclusive culture that supports positive employee relations. Specific leadership principle expected of the Specialist include: Contributes to the performance and results of the Quality department and RotaTeq® POD 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, draft investigations, approve investigations, regulatory document reviews, process change request activities, SOP development and review, execution of environmental sampling, and other Quality Assurance related functions.

Requirements

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.
Aseptic Manufacturing
Audits Compliance
Corrective and Preventive Action (CAPA)
Documentation Review
GMP Compliance
Quality Assurance (QA)
Quality Assurance Tools
Quality Auditing
Quality Management Systems (QMS)
Quality Standards
Root Cause Analysis (RCA)

Nice To Haves

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.

Responsibilities

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 audits as it relates to compliance concerns and communicates and manages any resulting corrective action plan.
Performs 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. Note: Specialists and Senior Specialists with a Science Degree are the only personnel authorized to perform the final release of intermediate (for further processing) and finished goods for domestic, EU, and international markets. Specialists and Senior Specialists (with a non-Science Degree) with equivalent experience are authorized to perform the final release of intermediate (for further processing) and finished goods for domestic and Canadian markets.
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 stability 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.
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.
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 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.
Promotes an environment conducive with the 12 inclusive behaviors, actively promotes an inclusive culture and leads by example.
Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents.
Ensure that activities are carried out in accordance with departmental budget.
Recognize and implement opportunities for efficiency and financial savings.
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 RotaTeq® 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.
Ensure that RotaTeq® 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 our company's 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.
Leads implementation of new programs / regulations / divisional processes at the site.
Participates in policy development activity both locally and with our company compliance experts externally. Interprets our company's 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.