GMP Supervisor

The Budd Group; Raleigh (NC); On-site; USD 26,000 - 37,000; Full time

Job summary

The Budd Group in Durham, NC is seeking a GMP Supervisor to oversee daily sanitization and cleaning in GMP process areas, ensuring adherence to cGMP, GDP, and ALCOA standards while maintaining environmental monitoring results. The role requires 1–3 years of experience, ability to lift up to 50 pounds, and a 2-2-3 schedule with potential weekends or overtime.

Pay is $23 per hour with a focus on precise documentation and collaboration with Quality, Facility, and Manufacturing teams.

Qualifications

• High school diploma or equivalent required.
• Experience in GMP environment preferred but not required.
• Attention to detail and good attendance are essential.

Responsibilities

• Perform routine GMP cleaning and sanitization in controlled areas.
• Ensure proper sanitization agent rotation and labeling.
• Complete GMP, GDP, and ALCOA documentation.
• Manage inventory and ordering of cleaning supplies.
• Assist with cycle counts and inventory of sanitization goods.
• Maintain organization of supply areas and gowning distribution.

Skills

Attention to detail

Teamwork

Communication skills

English proficiency

Education

High School Diploma or equivalent

Job description

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 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES 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

Other Responsibilities Include-

• 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 the 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, 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

REASONING ABILITY

• 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

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 not required.
• Business computer hardware and software applications
• Attention to detail is required
• Excellent attendance record
• Must follow work instructions

PHYSICAL DEMANDS

PHYSICAL DEMANDS 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 accommodations may be made to enable individuals with disabilities 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 employee frequently is required to stoop, kneel, crouch, or crawl. The employee is occasionally required 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 adjust focus. Strict adherence to dress code per each site, including no cosmetics (make-up, nail polish, cologne, perfume, etc.) and/or jewelry (not including singular wedding bands or medical alert bracelets) may be worn in the GMP process areas. Subject to extended periods of standing, walking, pushing and pulling, bending and crouching, climbing, and lifting of equipment and/or materials weighing up to 50 pounds. Continuous mental and visual attention to manufacturing functions. Continuous standing and walking throughout the work day.

WORK ENVIRONMENT

WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee may be subject to exposure to infectious waste, diseases, conditions, etc. including AIDS and Hepatitis B viruses. The noise level in the work environment is usually moderate.

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