ACM Quality Supervisor

OVERVIEW:

The objective of the Quality Supervisor 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:

• Consolidate and review daily reports from Quality. 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 Site Manager, and Quality 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.
• Assist with any level of cleanings as required, when on shift.
• Assist with re-trainings classes as assigned by Site Manager.

Perform hands-on inspections to ensure:

• Cleaning Technicians handwritten entries in facility logbooks are without error.
• Review digital log books to ensure that the SOW is reconciled for the date and area.
• 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 (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 Customer Quality Team and ACM chain of command.

· Conduct and develop root cause analysis for deviations.

· Attend Customer Quality Walkthroughs (GEMBA walkthroughs) in various building.

Hours

· Hours after training will be 6:00 AM to 2:30 PM and 6:00 PM to 2:30 AM and the days of the week will be determined by the site manager.

DIRECT REPORTS TO THIS POSITION:

• Site Leads, Assistant Leads, and Technicians.

REPORTS TO:

• Site Manager

Job Type: Full-time

Pay: From $25.00 per hour

Expected hours: No more than 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Evening shift
• Holidays
• Monday to Friday
• Night shift
• Overtime
• Weekends as needed

Experience:

• QA/QC: 2 years (Preferred)

Ability to Commute:

• Frederick, MD 21703 (Required)

Ability to Relocate:

• Frederick, MD 21703: Relocate before starting work (Required)

Work Location: In person

Salary : $25