Quality Control Supervisor
Company Name:
Thermo Fisher Scientific
Expertise Quality Assurance
Education Bachelors
Job Type Full-time
Location United States - Michigan - Kalamazoo
Job Level Manager
Posting date: October 21, 2014
Position
Summary:
Supervise Quality Control Inspectors, Label Control personnel, and Quality laboratory personnel - including, but not limited to, daily activities, e-time,PMDand scheduling and support.
Monitor, review, and approve the investigation of out-of-specification (OOS) laboratory events. Assist manufacturing in investigations related to OOS events.
Record and monitor bulk and finished product and raw material non-conformities. Ensure corrections are made as needed and approve closure of NCR. Provide data as needed to evaluate supplier quality.
Monitor, review and approve deviations (product and procedural). Work with manufacturing and quality personnel to ensure any corrections and/or corrective actions are appropriate for the incident.
Track / trend data analysis for OOS, deviations and non-conformities and report to management through Quarterly Quality Systems Management Review and Monthly Key Business Metrics.
Elevate large and /or continuing issues to the Quality Manager to be handled through the CAPA system.
Provide support for Lab/packaging validation and testing.
Assist Quality Manager in providing training to the organization on QSR 21 CFR part 820 andISO13485 requirements.
Lead and participate on Practical Process Improvement (PPI) teams.
Serve as Quality liaison for shop floor quality concerns and feedback.
Review and write/revise Quality and laboratory SOP's on a continuous basis.
Compliance with all company policies and procedures (safety, regulatory, etc.).
Minimum Requirements/
Qualifications:
Bachelors degree in a science related field
Minimum 5 years experience in a quality department (manufacturing and or laboratory) working with FDA regulated products (ex: pharmaceuticals, medical diagnostics/devices, food or dietary supplements)
Minimum 2 years experience in a supervisory role (supervising quality lab and /or quality inspectors)
Experience writing and/or approving out-of-specification investigations, deviations and non-conformances
Experience in a liquid filling manufacturing environment
Experience working with FDA regulated products (Medical Device/IVD preferred) (pharmaceutical, dietary supplement or food experience is acceptable).
Knowledge of ISO13485 / FDA QSR 21 CFR Part 820 / 803 requirements preferred, 21 CFR Part 110, 111 or 211 is acceptable.
Proficient in MS applications (Excel, Word, Outlook)
Excellent communication and attention to detail
Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude
Must demonstrate leadership skills
Familiarity with Code of federal regulations (FDA) and/or ISO 13485
Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
Knowledge of statistical data analysis tools and techniques.
Excellent communication skills both written & oral
Excellent computer skills, particularly spreadsheets/graphical software tools (e.g. Excel)
Less than 5%25%20travel (US, European & International)
Non-Negotiable Hiring Criteria:
Bachelors degree in a science related field
Two years experience as a Quality supervisor in a regulated environment (supervising laboratory and/or manufacturing quality personnel)
This position has not been approved for Relocation Assistance.
Skills/Requirements:
BachelorsEstimated Salary: $20 to $28 per hour based on qualifications.
Thermo Fisher Scientific
Expertise Quality Assurance
Education Bachelors
Job Type Full-time
Location United States - Michigan - Kalamazoo
Job Level Manager
Posting date: October 21, 2014
Position
Summary:
Supervise Quality Control Inspectors, Label Control personnel, and Quality laboratory personnel - including, but not limited to, daily activities, e-time,PMDand scheduling and support.
Monitor, review, and approve the investigation of out-of-specification (OOS) laboratory events. Assist manufacturing in investigations related to OOS events.
Record and monitor bulk and finished product and raw material non-conformities. Ensure corrections are made as needed and approve closure of NCR. Provide data as needed to evaluate supplier quality.
Monitor, review and approve deviations (product and procedural). Work with manufacturing and quality personnel to ensure any corrections and/or corrective actions are appropriate for the incident.
Track / trend data analysis for OOS, deviations and non-conformities and report to management through Quarterly Quality Systems Management Review and Monthly Key Business Metrics.
Elevate large and /or continuing issues to the Quality Manager to be handled through the CAPA system.
Provide support for Lab/packaging validation and testing.
Assist Quality Manager in providing training to the organization on QSR 21 CFR part 820 andISO13485 requirements.
Lead and participate on Practical Process Improvement (PPI) teams.
Serve as Quality liaison for shop floor quality concerns and feedback.
Review and write/revise Quality and laboratory SOP's on a continuous basis.
Compliance with all company policies and procedures (safety, regulatory, etc.).
Minimum Requirements/
Qualifications:
Bachelors degree in a science related field
Minimum 5 years experience in a quality department (manufacturing and or laboratory) working with FDA regulated products (ex: pharmaceuticals, medical diagnostics/devices, food or dietary supplements)
Minimum 2 years experience in a supervisory role (supervising quality lab and /or quality inspectors)
Experience writing and/or approving out-of-specification investigations, deviations and non-conformances
Experience in a liquid filling manufacturing environment
Experience working with FDA regulated products (Medical Device/IVD preferred) (pharmaceutical, dietary supplement or food experience is acceptable).
Knowledge of ISO13485 / FDA QSR 21 CFR Part 820 / 803 requirements preferred, 21 CFR Part 110, 111 or 211 is acceptable.
Proficient in MS applications (Excel, Word, Outlook)
Excellent communication and attention to detail
Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude
Must demonstrate leadership skills
Familiarity with Code of federal regulations (FDA) and/or ISO 13485
Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
Knowledge of statistical data analysis tools and techniques.
Excellent communication skills both written & oral
Excellent computer skills, particularly spreadsheets/graphical software tools (e.g. Excel)
Less than 5%25%20travel (US, European & International)
Non-Negotiable Hiring Criteria:
Bachelors degree in a science related field
Two years experience as a Quality supervisor in a regulated environment (supervising laboratory and/or manufacturing quality personnel)
This position has not been approved for Relocation Assistance.
Skills/Requirements:
BachelorsEstimated Salary: $20 to $28 per hour based on qualifications.
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