Quality Associate - Memphis, TN

Description

Natureplex is a privately held company that was first started in 2001 and has been growing exponentially each year. We offer our own control brand but are also very strong in private label and contract packaging of enemas, feminine hygiene products, over-the-counter medications, and personal care products. We currently have two locations, one in Olive Branch, MS and one in Memphis, TN. We are rapidly growing which means there are opportunities for advancement. We currently have an immediate opening for a Quality Assurance Associate at our Memphis, TN location.

We offer benefits that include:

• Medical Insurance (we pay 80% employee coverage and 20% for dependent coverage)

• Dental insurance

• Vision

• Voluntary Life

• Short Term Disability

• Vacation

• 401(k) with Company Matching

• Company paid life insurance

Natureplex is an equal opportunity employer.

Natureplex participates in E-verify.

Requirements

Summary

Perform QA functions to ensure that the product manufacturing process is Title 21 Part 210, 211 compliant.

Essential Functions

· Support manufacturing with quality line inspections and line clearance per standard operating procedure.

· Create controlled document and label issuance as part of batch record.

· Manage logbook issuance and reviews throughout the facility

· Perform sampling of components and raw materials for analytical testing.

· Perform Good Manufacturing Practices (GMP) documentation and review, meeting ALCOA standards.

· Adhere to all applicable FDA regulatory requirements.

· Provide support for deviation investigations, change controls, document controls, audits, APRs, as needed.

· Provides support with internal and regulatory audits/inspections, as needed.

· Support all QA related chain of custody activities, particularly for product quarantines, retains, return inspections.

· Maintain a clean and organized workspace to ensure the integrity of the product

· Follow all safety rules and regulations, by following SOPs and regulatory guidelines.

· Adhere to PPE requirements

· Other duties as needed

Competencies

· Decision Making – Uses sound judgment to make good decisions

· Teamwork – Interacts with people effectively; Able to share and receive information

· Work Standards – Sets and maintains high-performance standards; Pays close attention to detail.

· Motivation – Displays energy and enthusiasm in approaching a job; Commits to putting in the additional effort; maintains high

productivity and self-direction.

· Reliability – Takes personal responsibility for job performance; Completes work promptly and consistently.

· Adaptability – Adapts to changing work environments, work priorities, and organizational needs.

· Planning and Organizing – Plans and organizes tasks and work responsibilities to achieve the objective(s).

· Communication – Expresses ideas effectively; Organizes and delivers information appropriately; Listens actively.

· Integrity – Shares complete and accurate information; Maintains confidentiality and meets own commitments; Adheres to

organization policies and procedures.

· Initiative – Takes action to influence events; Generates ideas for improvement, suggests innovations; Does more than required.

Knowledge, Skills, and Abilities

· Computer skills, including Microsoft Office

· Preferred knowledge of NetSuite

Supervisor Responsibility

· None

Work Environment

· Manufacturing/Warehouse, hot and cold conditions

· Some loud noises, loud odors

· Office environment

· The noise level is moderate

Equipment Used and Physical Demands

· Must be able to stand for long periods of time and be engaged in frequent bending, stooping, squatting, pushing, and pulling of product and equipment.

· Can lift up to 50 pounds.

· Desktop computer, phone, copier/fax, scanner

Expected Hours of Work

· Monday - Friday workweek, 40 hours per week; Saturdays as needed

Travel

· Some local, less than 10%

Preferred Education and Experience

· High School Diploma, preferred

· 1 year of FDA regulated industry preferred but not required

Supervisory Function

· None

Additional Eligibility Qualifications

· None