Manufacturing GMP Technician in Bristol, Tennessee at Gregory Pharmaceutical Holdings Inc

Job Title: Manufacturing GMP Technician

Reports To: Sr. Manager, Manufacturing

Department: Manufacturing

FLSA Status: Non-Exempt

Location: Bristol

Summary: To ensure manufacturing rooms and equipment are cleaned to meet cGMP standards. Ensure washrooms, hallways, and gowning areas are routinely cleaned and cleaning appropriately documented. Perform inspections/verifications of clean equipment and rooms to ensure quality standards are met. Perform and document room clearances to mitigate the risk of product cross-contamination. Work with Manufacturing Operators to perform periodic checks for production in-process.

Essential Duties and Responsibilities:

1. Clean manufacturing equipment and rooms.
2. Clean common areas on the production floor including washrooms, hallways, and gowning areas.
3. Perform equipment cleaning verifications.
4. Perform clearances of rooms and equipment.
5. Ensure all cleaning agents used are properly labeled.
6. Ensure training remains current.
7. All other duties as may be assigned.

Knowledge Necessary to Perform the Job:

1. High level of attention to detail
2. Time management.
3. Determining the kind of tools and equipment needed to do a job.
4. The ability to read and understand written and oral instructions.
5. Ability to appropriately document activities

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

Problem Solving: The ability to apply general rules to specific problems and situations.

Oral Communication: The ability to communicate with individuals on all levels.

Written Communication: Understanding written sentences and instructions in work related documents. Able to produce documents that are clearly written.

Ethics/Professionalism: Works with integrity and ethically maintains confidentiality. Projects a professional and courteous business demeanor.

Organizational Support: Supports organization’s goals and values. Follows policies and procedures.

Adaptability: Expects delays and schedule changes. Open to change.

Attendance/Punctuality: Maintains regular and punctual attendance.

Initiative: Goes beyond what is expected to provide excellent customer service. Willingness to help other team members should the need arise.

Quality: Observes company quality policies and procedures.

Safety and Security: Observes safety and security procedures. Reports safety concerns to management.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or abilities required of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience: High School Diploma or GED equivalent.

Language Ability: The ability to listen to and understand information and ideas presented through spoken words and sentences.

Math Ability: Basic math skills with the ability to read liquid measurements.

Reasoning Ability: Is able to think about something in a logical way in order to form a conclusion or judgment.

Computer Skills: To perform this job successfully, an individual should have basic computer skills.

Work Environment and Physical Demands: The work environment characteristics and physical demands 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 noise level in this work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand, walk, sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The ability to exert maximum muscle force to life, push, pull or carry objects. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include ability to adjust focus and see details at close range.