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.

Other duties may be assigned.

• 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 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 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.

#RAL123

The Budd Group Inc. is an equal opportunity employer, and all qualified applicants will be considered for employment without regard to race, color, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law or regulation. #LI-DNI