Job Description
This is a hybrid position, Remote Monday and Friday, onsite Tues/Wed/Thurs.
Top 3 5 Skills Needed for each role
1. Quality Systems
2. Good Communication Skills
3. Project Management
4. Familiar with Aseptic Process
5. Combination Product
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.
Responsibilities
Top 3 5 Skills Needed for each role
1. Quality Systems
2. Good Communication Skills
3. Project Management
4. Familiar with Aseptic Process
5. Combination Product
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.
Responsibilities
- 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)
- 401(k)
- Medical, Dental and Vision Insurance
- Term Life Insurance
- Accidental Death and Dismemberment
- Long Term Disability
Numbers & Facts
| Location | Waukegan, IL |
| Industry | Staffing/Employment Agencies |
| Salary | $34–$39 Per Hour |
| Company Size | 10 to 19 employees |
| Website | http://www.colcon.com |
About Company
Skills
- Analysis Skillsunmatched
- Asepsisunmatched
- Biotech and Pharmaceuticalunmatched
- Calendar Managementunmatched
- Communication Skillsunmatched
- Corporate Complianceunmatched
- Data Managementunmatched
- Dental Insuranceunmatched
- Documentationunmatched
- Government Regulationsunmatched
- Maintain Complianceunmatched
- Metricsunmatched
- Performance Managementunmatched
- Performance Tuning/Optimizationunmatched
- Process Improvementunmatched
- Product Shipmentsunmatched
- Project Developmentunmatched
- Project Estimatesunmatched
- Project Evaluationunmatched
- Project/Program Managementunmatched
- Quality Assuranceunmatched
- Quality Assurance Methodologyunmatched
- Regulationsunmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Vision Planunmatched
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.
Free resume templatesFree resume builder
Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.
Free resume builder