Technical Services Compliance Specialist

    • Missoula, MT

Site Name: USA - Montana - Hamilton
Posted Date: Jan 23 2020
Are you energized by a packaging technology role that allows you to enhance your project management skills in a state-of-the-art production environment? If so, this TS Compliance Specialist role could be an exciting opportunity to explore.

In this position, you will provide departmental direction in Management of Change, CAPA, and Engineering project management. Responsible for providing technical, compliance, operational, and organizational support to Technical Services (TS) leadership through planning, scheduling, risk management, and change management. Champions the voice of TS leadership in proactive customer engagement for decisions affecting resource allocation and project prioritization.

Ensures statutory compliance and business continuity by mastering and driving compliance schedules coordinated with production demands to maximize the operational capabilities of GSK Hamilton. Actively promotes the success of the TS managed programs through collaboration, education and program promotion.
Represent TS in the tracking of procurement schedules for compliance critical contracts and expenditures, developing and packaging funding requests for compliance driven change expectations, and acting as a finance liaison to plan expenditures for current and out years budgeting.

Environment Health & Safety : Responsible to the TSBC supervisor for the interpretation, communication, application, and promotion of safety, process, and environmental compliance.
Promotes safety culture.
Lead safe work practices to ensure the safety of co-workers, product, equipment, and self.
Quality & Compliance : Ensures all activities are executed following quality and regulatory standards. Manages coordination and schedule adherence for internal standard gap assessments. Promotes a quality mindset and quality excellence approach to all activities. Revises SOPs as assigned. Complies with SOPs and Departmental Documentation requirements. Attends all mandatory training and maintains training forms and files. Adhere to all GSK policies and procedures as applicable for functional area.
Accountability : Ability to manage multiple projects and tasks in order to achieve deliverables and adhere to timelines and budgets. Ensures efficient coordination of projects and tasks as assigned by supervisor. Proactively keep process owners and supervisor informed of progress and activities. Deal positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves.
Operational Excellence : Proactively identify opportunities for process improvements and presents ideas to process owner, Lead, or Supervisor. Assist in monitoring and reporting of KPI's and metrics.
Authority:

  • Drive individual performance and accountability
  • Responsible for ensuring that scheduled work is performed on time in an appropriate manner as per GSK procedures and guidelines
  • Escalate issues that could present a noncompliance or an unsafe work environment.


This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Management of Change Coordinator
    • Promote successful site change management through support of Management of Change for Technical Services.
    • Create and maintain project plans for TS
    • Create and maintain resource model for TS personnel
    • Assist with departmental project prioritization through project management techniques and technical support and cross functional collaboration.
    • Pro-grammatically track TS procurement priorities and report to TS leadership
    • Attend PMT meetings as necessary
    Investigation Champion
    • Support deficiency investigations, gathering data on equipment/facility problems and implementing lean and 6-sigma tools, such as DMAIC, 5 whys, FMEA, cause & effect diagrams, and document results in reports, in order to identify the cause of the problem.
    • Support and track Engineering and Process Safety studies and their outcomes to include fire risk assessments, HAZOP studies, What-if/Checklist investigations, and FMECA.
    • Provide timely escalation of complex and difficult problem solving issues to cross-functional teams for investigation
  • Inspection Readiness
    • Support internal, external global and regulatory agency audits as subject matter expert.
    • Assist with the organization, preparation and presentation of Technical Services topics during internal and third party audits.
    • Assist with corrective actions related to Technical Services topics.
  • OE
    • Champion departmental OE initiatives through tracking and trending system performance to target
    • Maintain Lean Boards specific to project management
    • Provide weekly compliance metrics to TSLT
    • Compile monthly TS metrics
  • TS Support
    • Develop, author and modify departmental documents as needed in support of daily operations and implement OE initiatives within primary area of responsibility.
    • Ensure compliance to GSK policies and procedures for the management of the Technical Service department for facilities and equipment.
    • Compliance to good documentation practices and "right the first time".
    • Support development and adherence to site EHS programs and compliance
    • Escalate issues that could present noncompliance or an unsafe work environment

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
  • Possession of a bachelor's degree and 5 or more years of related experience with Microsoft Office applications, Project Management, Process Safety Management systems, and GMP (or other highly regulated) industry management.
  • Ability to work on assignments that are complex in nature, in which independent action and a high degree of initiative are required in resolving problems and developing recommendations.
  • Ability to influence others, and lead/ work in cross functional group dynamic.


Preferred Qualifications:
If you have the following characteristics, it would be a plus:
  • Working knowledge of pharmaceutical facilities, equipment and systems including a technical understanding of industry and engineering practices related to the business in order to apply knowledge to daily activities.
  • Demonstrated problem solving and investigation skills.
  • Knowledge of GMP's, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality and safety operations and compliance.
  • Working knowledge of OSHA 1910.119 Process Safety Management Program expectations
  • Experience with the preparation and presentation of technical topics during internal and third party audits.
  • The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
  • The ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy.
  • Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes.
  • Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production, EHS and QA. Ability to work in a highly complex matrix environment.
  • Able to prioritize and decide appropriate course of actions and to effectively implement decisions.
  • Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
  • Able to maintain attention to detail while executing multiple tasks.
  • Able to perform job duties with minimal supervision.
  • Must operate cross-functionally and be able to lead in a matrix organization.
  • Sense of urgency, flexibility and accountability.
  • High level of computer skills required. Microsoft Office suite required; SAP/Sharepoint/CAD preferred.
  • Maintain current on developments in the field and according to GSK Standards.
  • Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
  • Maintain a high level of integrity while balancing multiple priorities and responsibilities.

Why GSK?
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness


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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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