QA Senior Specialist

Job Description

Job Description

Description:

• The QA Senior Specialist is responsible for providing quality assurance support for the pharmaceutical plant.

• This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

• Include information about the accountability and scope.

• Develop plans, coordinates and drives for execution Quality projects across multiple site QA areas.

• Coordinate with site QA planners to achieve project deliverables.

• Coordinate with centralized function the deployment of global Pharma 3 initiatives.

• Analyze, manage and maintain data for cycle times, touch times, and tasks/process lists to optimize QA processes performance.

• Drive for development, improvement and maintenance of site QA planning and scheduling activities.

• Assure QA areas under scope of the project implement and maintain visual management tools to monitor key QA processes.

• Analyze and report metrics for planned and unplanned activities for key QA processes.

• Anticipates and identifies areas of risk and mitigates risks through early risk assessments and implementation of fallback / mitigation strategies.

• Lead development of the Project Charter and documents the requirements that satisfy the stakeholders' needs and expectations.

• Establish project objectives and criteria for evaluating project results and activities of the project team.

• Support Regulatory inspections for new market introduction.

• Lead and or coordinate Compliance and Performance improvement projects.

• Provide status to site management of the assigned projects.

• Maintains an effective liaison and cooperative relationship with Quality areas from Third Party Contractors (TPC)

• Travel: 3-4 trips per year to Grand Rapids, Michigan.

• Daily Work Schedule Expectations 8-5

Requirements:

• Bachelor's degree required.

• Strong pharmaceutical quality/compliance experience

• Experience supporting manufacturing or combination-product/device projects.

• Experience with third-party manufacturing

• Experience with combination products or medical devices is preferred.

• Quality Systems

• Good Communication Skills

• Project Management

• Familiar with Aseptic Process

• Combination Product

• Strong Quality/Compliance experience, including:

  • Investigations

  • Incidents

  • Nonconformance

  • CAPA

  • Change Control

  • PM-related activities

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities