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 . Job Duties to include: Summary: This position requires strict adherence to current Good ManufacturingPractices (cGMPs), established cleaning practices and procedures, and compliance withquality standards and regulations. The purpose of the cleaning and sanitization programis to control contamination and to serve as a corrective action for the loss of control forexcursion contamination. Standard Operating Procedures (SOPs) must be followed andstrictly enforced to ensure acceptable environmental monitoring results of the cleanedGMP environment.May be required to work weekends, holidays, and overtime if needed. ESSENTIAL DUTIES AND RESPONSIBILITIES Include any or all of the following.Other duties may be assigned.● Responsible for routine daily, weekly, monthly, and quarterly room sanitizationin GMP process areas● Responsible for non-routine sanitization in the GMP process areas due to theenvironmental excursion, process requirements, or facility maintenance andconstruction● Responsible for verifying that the proper sanitization agent rotation isfollowed, proper labelling including expirations and GDP, and that theappropriate sanitization agent is used for each cleaning assignment● Responsible for completing required GMP, GDP, and ALCOA documentationto ensure records are accurately and adequately maintainedcontemporaneously● Responsible for mixing and disposal of sanitization solutions on a daily basis● Responsible for disposal of waste from GMP manufacturing process areawaste 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 notlimited to clean room wipes, gloves, face masks, hairnets, shoe covers,cleaning agents, etc.● Responsible for stocking and maintaining GMP manufacturing process areaswith gloves, face masks, hairnets, laundered and disposable gowningarticles, and sanitizing equipment and supplies● Responsible for organization and upkeep of sanitization supply areas andgeneral manufacturing supply areas● Responsible for organization and distribution of gowning items (launderedand disposable) within the GMP manufacturing process areas on a dailybasis to ensure proper inventory levels● Responsible for participating in cycle counting and inventory of sanitizationsupplies and gowning articles in order to maintain inventory levels for timelyreordering Other Responsibilities Include-● Collaborate with Manufacturing, Facility, and Quality teams to manageschedules necessary to clean the GMP controlled environment and supportareas to comply with GMP requirements● Participate in required training on the use of sanitization reagents andequipment● Strictly follows Standard Operating Procedures● Must pass cleanroom gowning qualification test in order to enter and sanitizethe GMP filling process rooms● Strictly adheres to client protocol within controlled areas, such as airlocks.● Sanitization activities will be performed with ceiling mops, wall mops, floormops, and wipers● Understands and follows proper solvent handling procedures (EHS) andpersonal protective equipment (PPE) specific to each site and area. ● Performs related duties as assigned REASONING ABILITY● Accurate GMP documentation and sign off on work performed with anemphasis on Good Documentation Practices (GDPs)● Communicating clearly and concisely, both orally and in writing in Englishaccording to GDP guidelines.● Ability to work in a team environment and independently● Establish and maintain collaborative working relationships with internal andexternal customers● Providing excellent customer service with both internal and externalcustomers QUALIFICATIONS● 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 EDUCATION and/or EXPERIENCE● High School Diploma or equivalent● Prior experience of cleaning a GMP controlled environment is a plus but notrequired.● Business computer hardware and software applications● Attention to detail is required● Excellent attendance record● Must follow work instructions PHYSICAL DEMANDS The physical demands described here are representative ofthose that must be met by an employee to successfully perform the essential functions ofthis job. Reasonable accommodations may be made to enable individuals withdisabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk,use hands to finger, handle or feel, and reach with arms and hands. The employeefrequently is required to stoop, kneel, crouch, or crawl. The employee is occasionallyrequired to talk or hear. The employee must frequently lift and/or move up to 50 pounds.Specific vision abilities required by this job include close vision, and ability to adjustfocus.● Strict adherence to dress code per each site, including no cosmetics(make-up, nail polish, cologne, perfume, etc.) and/or jewelry (not includingsingular wedding bands or medical alert bracelets) may be worn in the GMPprocess areas● Subject to extended periods of standing, walking, pushing and pulling,bending and crouching, climbing, and lifting of equipment and/or materialsweighing up to 50 pounds● Continuous mental and visual attention to manufacturing functions● Continuous standing and walking throughout the work day WORK ENVIRONMENT The work environment characteristics described here arerepresentative of those an employee encounters while performing the essential functionsof this job. Reasonable accommodations may be made to enable individuals withdisabilities to perform the essential functions. The employee may be subject to exposureto infectious waste, diseases, conditions, etc. including AIDS and Hepatitis B viruses.The noise level in the work environment is usually moderate.   #RAL123