GMP Cleanroom Quality Lead
Swiftwater, PA Swiftwater, PA Full-time Full-time $47,000 - $53,000 a year $47,000 - $53,000 a year 1 day ago 1 day ago 1 day ago Overview:
The objective of the Quality Manager is to have sitewide oversight, to ensure and oversee that all Standard Operating Procedures (SOPs) are properly taught and followed and review good documentation.
Ensure that all cleaning, disinfecting, and documentation is performed to expectations and adhere to the customer's Good Manufacturing Practices (GMP) and Good Documentation practices (GDP).
MINIMUM
Qualifications:
The ability to read and understand in English all revisions of applicable Customer assigned SOPs, policies and procedures.
Computer literacy:
The ability to compile and enter data on MS Excel spreadsheets on iPad / tablet or workstation.
The ability to become qualified as a train the trainer on customer's SOPs for area of responsibility and site wide as appropriate.
The ability to work flexible hours including holidays, weekends, overtime, be on-call and available for special assignments.
Complete all training requirements for specific work areas.
The ability to write English with good handwriting techniques and limited errors.
ESSENTIAL JOB DUTIES:
Oversee 5 Quality Managers, perform quarterly evaluations.
Train and coach incoming personnel as necessary.
Consolidate and review daily reports from Quality Managers.
Ensure level of cleaning personnel is adequate for specific level of required clean.
Liaison with Client on cleaning schedule to ensure optimal cleaning times.
Work with the Leads, Assistant Building managers, and Quality Managers to ensure training certification levels meet goals and staff is current on all applicable training for their assigned area.
Consolidate and review all assigned documentation for entry errors and initiate correction process immediately to ensure all corrections are made in compliance to SOP.
Consolidate and track entry errors by area and by type and compile data into MS excel spreadsheet to be utilized in the Key Performance Indicator (KPI) presentations.
Perform hands-on inspections to ensure:
Cleaning Technicians handwritten entries in facility logbooks are without error.
All dwell times are adhered to in accordance with SOP's and are being accurately recorded in logbook entries.
Appropriate level of clean is being performed according to client's SOP's All chemical related documentation is accurate including lot numbers and expiration dates.
Provide clarification to any SOP as necessary upon request.
Make suggestions to you Sanofi management if revisions need to be made to the SOPs.
ESSENTIAL SAFETY:
Safety is of utmost importance:
Hot Water for Injection (HWFI) and Water for Injection (WFI) are extremely hot lines raised to steam levels each night.
Aseptic Cleaners must use caution and wear appropriate Personal Protective Equipment (PPE) such as safety shoes, safety glasses, breathing masks, rubber gloves around electrical equipment and proper clothing for the specific area in addition to cleanroom gowning.
Vacuum cleaners and mop buckets are extremely heavy when full, so ensure the use of proper lifting techniques for emptying must be followed.
Walking surfaces may be wet, so caution and situational awareness must be used at all times.
Work safely and notify your manager of potential safety hazards and near misses.
OTHER JOB DUTIES Ensure correct communications both up and down the chain of command.
Partner with Customer Management (PI, QA and APM) to review any deviations and assist with investigations, develop new systems as required and ensure appropriate training is executed.
Develop and issue coaching memos in the event of policy or procedure violation.
Conduct and coordinate corrective action training / facilitate training.
Ensure that all deviation corrections are in place and re-training is facilitated.
Conduct deviation investigations, corrective action preventative action (CAPA), remedial training.
Escalate any deviations to Quality Team and ACM chain of command Conduct and develop root cause analysis for deviations Attend Quality Walkthroughs (GEMBA walkthroughs) in various building DIRECT REPORTS TO THIS POSITION:
QC employees REPORTS TO:
Assistant Site Manager and Site Manager ADDITIONAL ITEMS:
ACM is a EOE We reserve the right to modify this job description at any time.
PAY RATE:
Job Type:
Full-time Job Type:
Full-time Pay:
$47,000.
00 - $53,000.
00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule:
Evening shift Holidays Night shift On call Overtime Weekend availability Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
The objective of the Quality Manager is to have sitewide oversight, to ensure and oversee that all Standard Operating Procedures (SOPs) are properly taught and followed and review good documentation.
Ensure that all cleaning, disinfecting, and documentation is performed to expectations and adhere to the customer's Good Manufacturing Practices (GMP) and Good Documentation practices (GDP).
MINIMUM
Qualifications:
The ability to read and understand in English all revisions of applicable Customer assigned SOPs, policies and procedures.
Computer literacy:
The ability to compile and enter data on MS Excel spreadsheets on iPad / tablet or workstation.
The ability to become qualified as a train the trainer on customer's SOPs for area of responsibility and site wide as appropriate.
The ability to work flexible hours including holidays, weekends, overtime, be on-call and available for special assignments.
Complete all training requirements for specific work areas.
The ability to write English with good handwriting techniques and limited errors.
ESSENTIAL JOB DUTIES:
Oversee 5 Quality Managers, perform quarterly evaluations.
Train and coach incoming personnel as necessary.
Consolidate and review daily reports from Quality Managers.
Ensure level of cleaning personnel is adequate for specific level of required clean.
Liaison with Client on cleaning schedule to ensure optimal cleaning times.
Work with the Leads, Assistant Building managers, and Quality Managers to ensure training certification levels meet goals and staff is current on all applicable training for their assigned area.
Consolidate and review all assigned documentation for entry errors and initiate correction process immediately to ensure all corrections are made in compliance to SOP.
Consolidate and track entry errors by area and by type and compile data into MS excel spreadsheet to be utilized in the Key Performance Indicator (KPI) presentations.
Perform hands-on inspections to ensure:
Cleaning Technicians handwritten entries in facility logbooks are without error.
All dwell times are adhered to in accordance with SOP's and are being accurately recorded in logbook entries.
Appropriate level of clean is being performed according to client's SOP's All chemical related documentation is accurate including lot numbers and expiration dates.
Provide clarification to any SOP as necessary upon request.
Make suggestions to you Sanofi management if revisions need to be made to the SOPs.
ESSENTIAL SAFETY:
Safety is of utmost importance:
Hot Water for Injection (HWFI) and Water for Injection (WFI) are extremely hot lines raised to steam levels each night.
Aseptic Cleaners must use caution and wear appropriate Personal Protective Equipment (PPE) such as safety shoes, safety glasses, breathing masks, rubber gloves around electrical equipment and proper clothing for the specific area in addition to cleanroom gowning.
Vacuum cleaners and mop buckets are extremely heavy when full, so ensure the use of proper lifting techniques for emptying must be followed.
Walking surfaces may be wet, so caution and situational awareness must be used at all times.
Work safely and notify your manager of potential safety hazards and near misses.
OTHER JOB DUTIES Ensure correct communications both up and down the chain of command.
Partner with Customer Management (PI, QA and APM) to review any deviations and assist with investigations, develop new systems as required and ensure appropriate training is executed.
Develop and issue coaching memos in the event of policy or procedure violation.
Conduct and coordinate corrective action training / facilitate training.
Ensure that all deviation corrections are in place and re-training is facilitated.
Conduct deviation investigations, corrective action preventative action (CAPA), remedial training.
Escalate any deviations to Quality Team and ACM chain of command Conduct and develop root cause analysis for deviations Attend Quality Walkthroughs (GEMBA walkthroughs) in various building DIRECT REPORTS TO THIS POSITION:
QC employees REPORTS TO:
Assistant Site Manager and Site Manager ADDITIONAL ITEMS:
ACM is a EOE We reserve the right to modify this job description at any time.
PAY RATE:
Job Type:
Full-time Job Type:
Full-time Pay:
$47,000.
00 - $53,000.
00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule:
Evening shift Holidays Night shift On call Overtime Weekend availability Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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