OXB - GMP Supervisor

GMP Supervisor

Pay Rate: $23.00/hr

Hours and Days: 2-2-3 work Schedule

Location:

Durham, NC

Lifting Restrictions:
Must be able to lift 35 lbs repetitively

Experience

Required:

1-3 years years

Summary:

This position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning practices and procedures, and compliance with quality standards and regulations. The purpose of the cleaning and sanitization program is to control contamination and to serve as a corrective action for the loss of control for excursion contamination. Standard Operating Procedures (SOPs) must be followed and strictly enforced to ensure acceptable environmental monitoring results of the cleaned GMP environment.
May be required to work weekends, holidays, and overtime if needed.

Include any or all of the following.

• Responsible for routine daily, weekly, monthly, and quarterly room sanitization in GMP process areas
• Responsible for non-routine sanitization in the GMP process areas due to the environmental excursion, process requirements, or facility maintenance and construction
• Responsible for verifying that the proper sanitization agent rotation is followed, proper labelling including expirations and GDP, and that the appropriate sanitization agent is used for each cleaning assignment
• Responsible for completing required GMP, GDP, and ALCOA documentation to ensure records are accurately and adequately maintained contemporaneously
• Responsible for mixing and disposal of sanitization solutions on a daily basis
• Responsible for disposal of waste from GMP manufacturing process area waste receptacles on a regular basis
• Responsible for collecting full, soiled gowning article bags on a daily basis, and replacing with new bags
• Responsible for ordering general manufacturing supplies such as but not limited to clean room wipes, gloves, face masks, hairnets, shoe covers, cleaning agents, etc.
• Responsible for stocking and maintaining GMP manufacturing process areas with gloves, face masks, hairnets, laundered and disposable gowning articles, and sanitizing equipment and supplies
• Responsible for organization and upkeep of sanitization supply areas and general manufacturing supply areas
• Responsible for organization and distribution of gowning items (laundered and disposable) within the GMP manufacturing process areas on a daily basis to ensure proper inventory levels
• Responsible for participating in cycle counting and inventory of sanitization supplies and gowning articles in order to maintain inventory levels for timely reordering

• Collaborate with Manufacturing, Facility, and Quality teams to manage schedules necessary to clean the GMP controlled environment and support areas to comply with GMP requirements
• Participate in required training on the use of sanitization reagents and equipment
• Strictly follows Standard Operating Procedures
• Must pass cleanroom gowning qualification test in order to enter and sanitize
• Strictly adheres to client protocol within controlled areas, such as airlocks
• Sanitization activities will be performed with ceiling mops, wall mops, floor mops, and wipers
• Understands and follows proper solvent handling procedures (EHS) and personal protective equipment (PPE) specific to each site and area
• Performs related duties as assigned

• Accurate GMP documentation and sign off on work performed with an emphasis on Good Documentation Practices (GDPs)
• Communicating clearly and concisely, both orally and in writing in English according to GDP guidelines
• Ability to work in a team environment and independently
• Establish and maintain collaborative working relationships with internal and external customers
• Providing excellent customer service with both internal and external customers

• Current Good Manufacturing Practices (cGMP) is a plus but not required
• Good Documentation Practices (GDP) is a plus but not required
• Company policies and practices, including safety rules and regulations

• High School Diploma or equivalent
• Prior experience of cleaning a GMP controlled environment is a plus but not required
• Business computer hardware and software applications
• Attention to detail is required
• Excellent attendance record
• Must follow work instructions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable…