When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
Life Sciences Group (LSG) – BioProduction Group (BPG). Detroit, MI Peptone Manufacturing Site.
How will you make an impact?
As a Quality Manager of QA/QC, you will make an impact by:
Managing the site's Quality Control (QC) Laboratory and Quality Assurance activities pertaining to product release.
Managing and providing guidance to a team of Quality Assurance Professionals and Quality Control analysts responsible for conducting QC testing, batch record reviews/verifications and support of Quality Systems improvements efforts and projects.
Driving a culture of continuous Quality improvement by employing Thermo Fisher's Practical Process Improvement (PPI) concepts.
What will you do?
A working Quality Manager responsible for management of the daily activities of Quality Control and Quality Assurance functions pertaining to product testing and release.
Develop systems and methodologies to track QC testing schedules ensuring customer demands are met.
Create and Maintain laboratory performance metrics. Reports metrics internally and externally as required.
Ensures the accurate and timely completion of activities related to testing and projects.
Support Quality Assurance activities at the site including CAPA system improvements/compliance, product disposition, Change Control, Validation Activities, Batch Record Review Process, Customer Notification, Complaints Investigations, Manufacturing Area Support and regulatory support.
Supports complex and cross-functional quality topics and drives resolution and proactive solutions to all improvement efforts at the site including Quality Excellence projects and strategic goals and objectives.
May work directly with customers on complex critical quality investigations.
May perform statistical analysis to analyze trends, and works with manufacturing to investigate, conduct root cause analysis, recommend corrective actions for processes and products and to contribute to and track data to support site level (e.g. yield improvements, CAPA, complaint and scrap reduction).
Conduct necessary risk assessments to facility product lot dispositions.
Responsible for ensuring internal policies, customer expectations, and regulatory requirements are met.
Interfaces with suppliers and vendors to help resolve complex quality issues (e.g., investigations, troubleshoots raw materials issues).
How will you get here?
Minimum educational requirement Bachelor's degree in Engineering, Chemistry, Biology, Biochemistry or Environmental Sciences; or 5 plus years of equivalent experience.
A Minimum of 5 years of experience in quality assurance / quality control with direct supervisory responsibilities in a cGMP Pharmaceutical/Biotech or Life Science site.
Proven track records in managing QC laboratory environments and leading teams and achieving strategic Quality objectives.
Proven ability to lead groups, manage deliverables, adhere to due dates and maintain relationships
Requires a full functional knowledge of laboratory equipment and techniques.
Prior experience with the release and disposition of nonconforming product through the application of risk assessment and root cause analysis tools.
Prior experience with an electronic Quality Management system software utilized for product investigations and dispositions.
Proficiency in statistical tools, good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
Must possess self-motivation and ability to work in a team-oriented environment in order to support all daily functions of the labs.
Knowledge, Skills, Abilities
Advanced knowledge of ISO 13485 standards and FDA cGMP regulations (i.e 21 CFR 820).
Proficiency in Quality tools (e.g. FMEA, Risk Analysis, RCA, SPC, DOE GR&R, CPK Analysis, etc.)
Previous knowledge of quality systems software programs (change control, CAPA, Complaints Handling etc.).
Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below; ability to prepare high quality presentations and deliver them effectively.
Computer skills: knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must.
Knowledge of a statistical analysis tools and methodologies including the use of data software (Minitab, JMP…etc) is highly desirable.
Lean Sigma Green or Black Belt certified a plus.
ASQ CQE or CQM a plus.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
To Apply, please click the following link: https://thermofisher.contacthr.com/82509007
Apply on company website