Quality Assurance Specialist I

SUMMARY:

The Quality Assurance Specialist I is an entry-level, 100% on-site position that supports the day-to-day Quality Assurance (QA) department at our Dyersburg facility. This hands-on role is responsible for helping maintain compliance with current Good Manufacturing Practices (cGMP) and Quality Management System (QMS) requirements in a 503(b) outsourcing facility. The Quality Assurance Specialist I will work directly with Operations and Quality Control to ensure high product quality, regulatory compliance, and continuous improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Print, issue, reconcile, and archive GMP documentation.

· Review production batch records, logbooks, forms, and other GMP documentation for accuracy, completeness, and compliance.

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

· Inspect and disposition raw materials, packaging components, labels, in-process materials, and finished product.

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

· Assist with regulatory training and management.

· Assist with assuring all personnel are meeting federal and state regulations regarding compounding, personal protective equipment, aseptic technique, etc.

· Assign deviation numbers.

· Input data into reports.

· Maintain awareness of and compliance with all safety procedures, PPE requirements, and aseptic techniques.

· Communicate effectively with operations, Quality Control (QC), and other departments to support production and quality goals.

· Complete other QA-related tasks and duties as assigned by the Quality Assurance Manager.

SUPERVISORY RESPONSIBILITIES:

· None

REQUIRED QUALIFICATIONS:

· No prior experience required.

§ High school diploma/GED; 0-3 years of experience.

§ Associate’s degree in technical or scientific field; 0-2 years of experience.

§ Bachelor’s degree in technical or scientific field; 0-1 years of experience.

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

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

· Basic computer literacy (e.g., 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, including addition, subtraction, multiplication, division, percentages, and 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 manufacturing, compounding, or laboratory environment.

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

· Experience working with Quality Management Systems (QMS).

LANGUAGE SKILLS:

· Ability to read, understand, and follow written procedures, batch records, and regulatory documents in English.

· Ability to write clear and accurate records, reports, and log entries in accordance with GMP documentation practices.

· Strong verbal communication skills to effectively interact with team members, management, and other departments.

· Capable of understanding and applying technical terminology used in a pharmaceutical or regulated manufacturing environment.

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 while wearing cleanroom attire (e.g., gown, gloves, mask).

· Must be able to bend, kneel, stoop, and crouch 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 visual acuity sufficient to inspect products and read detailed documentation.

· Must be able to work in a controlled environment with extended periods of gowning and limited mobility.

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 an associate’s or bachelor’s degree in a scientific, technical, or quality-related field?

Experience:

• regulated manufacturing, and/ or compounding: 1 year (Preferred)
• batch record review: 1 year (Preferred)
• environmental monitoring, or product inspection processes: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Ability to Commute:

• Dyersburg, TN 38024 (Required)

Work Location: In person

Salary : $16 - $22