QC Environmental Monitoring Technician I

SUMMARY:

The Quality Control Environmental Monitoring Technician I is an entry-level, 100% on-site position that supports the day-to-day Quality Control (QC) department at our Dyersburg facility. This hands-on role is responsible for helping maintain compliance with current Good Manufacturing Practices (cGMP) and 503(b) regulatory standards. This position will work directly with Operations, Pharmacists, and Quality Assurance to ensure product quality, regulatory compliance, and continuous improvement. This position will conduct environmental monitoring of the manufacturing facilities and personnel, microbiology analysis of samples, visual inspections of raw materials and finished drug product, and manage sample submissions and results.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Request, review, and submit cGMP documentation.

· Collect and document air, surface, personnel, and water sample results from cleanroom, laboratory, and other controlled areas.

· Analyze collected samples for microbial and particulate content, ensuring results comply with internal and regulatory standards.

· Review QC records, logbooks, and forms for accuracy, completeness, and compliance.

· Perform data entry, document updates, and record-keeping activities within the Quality Management System (QMS) and spreadsheets.

· Ensure QC equipment is maintained and calibrated according to standard operating procedures and manufacturer requirements.

· Visually inspect raw materials, packaging components, labels, in-process materials, and finished products.

· Submit samples for 3rd party testing.

· Document sample results rom 3rd party laboratories.

· Assist with external and internal audits of the QMS and facilities (cleanrooms, laboratory, and warehouse)

· Maintain awareness of and compliance with all safety procedures, personal protective equipment (PPE) requirements, and aseptic techniques.

· Communicate effectively with Operations, Pharmacists, and Quality Assurance to support production and quality goals.

· Complete other QC-related tasks and duties as assigned by the Quality Control Manager.

REQUIRED QUALIFICATIONS:

· High school diploma or GED.

· No prior experience required.

· All required onboarding and role-specific training must be successfully completed within the first 90 days of employment to continue in the position. The training includes the following:

§ cGMP

§ Plate counting

§ Gowning Qualification

§ Visual inspection

§ Environmental Monitoring

§ Sample Submissions

§ Personnel monitoring

· Ability to follow written procedures and standard operating procedures (SOPs).

· Basic computer literacy (Microsoft Word, Excel, and Teams).

· Strong attention to detail and a commitment to accuracy.

· Ability to work independently and as part of a team in a regulated environment.

· Effective verbal and written communication skills.

· Ability to stand for extended periods and work in cleanroom attire (gown, gloves, mask).

· Willingness to undergo training in GMP regulations and quality procedures.

· Ability to perform basic math calculations:

§ Addition

§ Subtraction

§ Multiplication

§ Division

§ Percentages

§ Unit conversions.

· Must successfully pass a vision screening, a drug test, and a background check prior to employment.

PREFERRED QUALIFICATIONS

· Associate’s or bachelor’s degree in a scientific, technical, or quality-related field.

· Experience using SharePoint, Smartsheet, and MasterControl.

· Previous experience in a regulated (503(b), FDA, DEA) manufacturing, compounding, or laboratory environment.

· Exposure to batch record execution, environmental monitoring, or product inspection processes.

· Experience working with QMS.

PHYSICAL REQUIREMENTS:

· Ability to stand, walk, sit, reach, and perform manual tasks for extended periods.

· Must be able to lift up to 25 lbs. frequently and up to 50 lbs. occasionally.

· Must be able to work for extended periods while wearing cleanroom attire (e.g., gown, gloves, mask).

· Must be able to bend, kneel, stoop, crouch, and balance occasionally in the course of routine tasks.

· Must be able to use hands and fingers to handle or feel objects, tools, or controls with precision.

· Must have 20/20 unaided or corrected vision

· Must not be colorblind.

· Must have visual acuity sufficient to inspect products and read detailed documentation.

Join us in our commitment to maintaining the highest standards of environmental safety and quality assurance. Your expertise will play a vital role in our success!

Job Type: Full-time

Pay: $16.00 - $22.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Application Question(s):

• Do you have previous experience in a regulated (503(b), FDA, DEA) manufacturing, compounding, or laboratory environment ?

Shift availability:

• Day Shift (Preferred)

Ability to Commute:

• Dyersburg, TN 38024 (Required)

Work Location: In person

Salary : $16 - $22