IT Quality Assurance Manager jobs in Germantown, 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 are rapidly growing which means there are opportunities for advancement. We have two production facilities, one in Olive Branch, MS and one in Memphis, TN. We currently have an opening for a Quality Assurance Manager at our Olive Branch location.

Benefits and Perks

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

• Dental insurance

• Vision

• Voluntary Life

• Short Term Disability

• Vacation

• 401(k)

• Company paid life insurance

Natureplex is an equal opportunity employer.

Natureplex participates in E-verify.

Requirements

Summary

Manage Quality Assurance personnel and operations to assure conformance to all regulatory, quality system, internal and external   customer requirements.

Job Responsibilities

• Maintain the employee training program including conducting and/or coordinating training and ensuring training files and documentation are current.
• Monitor the performance of Quality processes, personnel and methods to assure conformance to regulatory, quality system, internal and external customer requirements. 
• Assess the effectiveness of processes, current specifications, test methods and personnel performance. 
• Tracking and Trending to assess regulatory compliance of:
• Incident Reports, including investigations, OOS investigations, deviations, etc.
• Corrective Action / Preventative Action Reports
• Customer Feedback / Complaints
• Document Control
• Change Control
• Participate in customer audits (internal and external) and Regulatory Audits/Inspections.
• Provide overall guidance and leadership with the internal audit program.
• Inherent in the processes of Quality is the interpretation of requirements, and the need to use careful judgment to determine compliance. It is critical for the   individual in this role to use sound judgment and demonstrate consistent decision-making. 
• Oversee ongoing production inspections 
• Management includes, but is not limited to: 
• Development and implementation of inspection and operational procedures 
• Establish departmental operating budget, guidelines and practice 
• Monitor and maintain the department personnel and material resources to meet departmental commitments 
• Establish personnel performance criteria and provide the necessary training and resources to meet the performance goals and objectives   
• Provide evaluation and performance rating for departmental personnel 
• Provide methods to communicate the quality status of materials and processes to internal customers, management and external suppliers 
• Ensure that department operation and practices comply with OSHA, material handling and facility safety requirements.

Skills and Qualifications

· Must have a bachelor’s degree in a scientific or technical field or equivalent work experience. 

· Must have computer skills including excel, word and email 

· Must have 3-5 years’ experience in a relevant industry (pharmaceutical, medical device, etc.) 

· Must be familiar with the relevant standards and regulatory requirements (ISO, GMP, etc.)