Quality Compliance Manager

About us:

We have been in business for over 33 years and continue to grow throughout the country.

We are currently looking for professional individuals with a strong work ethic to join our team in Framingham, MA to work alongside a local manufacturing company. We currently are accepting applications for an Assistant Site Manager to oversee the Cleaning techs who maintain our client's cleanrooms and laboratory space.

OBJECTIVE:

The objective of the Compliance Manager is to ensure that all Standard Operating Procedures (SOPs) are being instructed and adhered to and that the customer GMP cleaning and documentation expectations are met and that all associates are provided an environment to work that is safe and comfortable.

DIRECT REPORTS TO THIS POSITION:

Aseptic Cleaning Leads / Compliance Supervisors / Porters / Aseptic Cleaning Technicians

WE PROMOTE FROM WITHIN - MANY NEW POSITIONS NATIONWIDE

REQUIREMENTS:

This position must be available to work flexible hours (open availability) and be reachable by company issued cell phone off hours.

4 year Degree

All Applicants must be able to pass a drug screening and background check for employment consideration.

PREFERRED REQUIREMENTS:

Previous management experience is preferred.

Previous experience in a cleanroom environment is preferred

QC Manager will know all Customer assigned Standard Operating Procedures (SOPs) and be signed off in their area of responsibility and know the other areas SOPs.

This position must be available to work flexible hours and be available by phone and/or email

Keep current all SOP training up to date to ensure 100% Compliance.

JOB DUTIES:

CUSTOMER SERVICE:

Attend customer maintenance and other meetings as required to identify scheduling opportunities and any concerns. Come up with solutions to concerns and take appropriate action as required.

Contact the customer, trainer or subject matter expert if there are any questions pertaining to SPIs, SOPs, or Protocols. Make any suggestions to your manager if clarifications need to be made to the SOPs.

Ensure training is completed and submitted for entry into Veeva with a goal of 100% within 14 days of starting any training SOPs.

Meet with customer to review deviations if required, and support the customer in deviation investigations, corrective and preventative actions and assist with any information and problem solving and participate in ensuring preventative actions are implemented.

Track Site KPIs as directed by the Site Manager.

Any other duties requested by the customer or company.

OPERATIONS AND HUMAN RESOURCES:

Actively facilitate all required training and schedule cross training where needed.

Perform work site inspections and coaching by walking around.

Manage safety committee and investigate safety related incidents.

Ensure at a minimum that all training deviation corrective and preventative actions are trained and implemented in your area of responsibility. Assist with other areas as requested or appropriate.

Ensure staffing levels are met. Call in back-ups as required and interface with other assistant managers or supervisors to meet daily cleaning demands.

Receive and communicate all PTO requests to Site Manager for approval.

Ensure that dress code is met according to company and customer policy. Ensure that all employees have company issued uniforms/T-shirts.

Provide clarification to any SOP as necessary or requested by an associate.

Documented coaching memos or counseling’s need to be submitted to Site Manager for filing as required and/or assist associates when appropriate to train and coach because of a policy or procedure violation.

Perform injury report investigations and near misses for your department. Meet with the Customer’s safety representative as required. Notify the Customer’s safety manager of potential safety hazards.

Review Deviations and work with Site Manager or Compliance and Customer’s management to investigate, develop new systems as required. Ensure re-training is conducted and executed as appropriate.

Ensure employees are taking lunch and that they are taking lunch in appropriate areas and that they are punching in and out for lunch.

Ensure that all Customer policies are being met.

Submit daily report for hours worked in your area of responsibility to the Site Manager.

Ensure proper documentation process is followed. Cleaning technician verifies peers work and ensure that the supervisor reviews the documentation for accuracy and signs off. Sign off on documentation if supervisor is absent verifying observation and accuracy.

Review all GMP documentation for accuracy daily during shift and before leaving. Ensure errors are corrected according to GMPs. Ensure proper corrective action is taken and systems are put in place to improve cGMP documentation. Participate in tracking KPI’s and employee re-training.

On-call for coverage if supervisor is out or there is an emergency on your off-shift. If supervisor is cleaning, then this position acts as the supervisor observing the cleaning and for reviewing and signing off on the documentation.

COMPENSATION: $24.00-26.00/hr

ADDITIONAL ITEMS:

Any other duties requested by the company.

This job description may be changed at any time.

ACM/CTI is an equal opportunity employer.

Job Type: Full-time

Pay: $24.00 - $26.00 per hour

Benefits:

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

Schedule:

• 8 hour shift

Ability to Relocate:

• King of Prussia, PA: Relocate before starting work (Required)

Work Location: Multiple locations