Job Description

Job Purpose:

The Quality Operations Materials Management Specialist is responsible for the inspection, sampling, and disposition of any specified raw materials, production components, and resin. Specialists work with other departments to ensure receipt, sampling, and releases are within compliance and completed in a timely manner.

Qualified personnel will use Nephron’s electronic inventory system and complete all corresponding documentation to ensure compliance with regulatory standards.

Essential Duties and Responsibilities:

• Perform quality checks on incoming raw materials, production components, and resin to ensure to ensure documentation and information on containers is accurate and complete.
• Oversee the disposition of raw materials, production components, and resin.
• Collect samples for incoming inspection based on MIL-STD 105E/ANSI/ASQ Z1.4.
• Utilize approved sampling supplies and inspection tools to collect samples or complete inspection.
• Provide guidance and training on how to perform quality operations procedures and processes.
• Regularly monitor lot status in inventory management system.
• Review quality procedures for continuous improvement and make necessary adjustments to match current business needs and industry best practices.
• Scan hard copy documents and file them in the appropriate electronic systems so they're easily accessible to appropriate groups, regardless of their location.
• Take ownership of the Quality Operations Materials Management mailbox and act as the main point of contact for sampling and disposition inquiries.
• Ability to pass required medical screenings to ensure safe handling of pharmaceutical raw materials used within the manufacturing process and participate in any periodic medical screenings as defined by company.

Supplemental Functions:

• Copying, filing, and scanning of documents.
• Perform other similar duties as required.

Job Specifications and Qualifications:

Knowledge & Skills:

• Strong understanding of quality operations and materials management procedures, standards, and best practices.
• Competent in Microsoft Word and Excel
• Experience with inventory management systems.
• Effective time management skills including prioritizing more immediate needs.
• Effective communication and interpersonal abilities to work with cross-functional, fast-paced teams.
• Ability to prioritize tasks, manage time efficiently, and meet deadlines.
• Familiar with relevant pharmaceutical industry regulations and compliance standards, such as cGMP and FDA regulations.
• Discretion in handling sensitive and confidential information.
• Strong critical thinking, analytical, problem-solving, and interpersonal skills.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.

Education/Experience:

• Minimum of 2 years of related experience in the pharmaceutical industry preferred.
• ISO-7 and/or ISO-5 cleanroom experience preferred.
• Bachelor’s degree preferred; High School Diploma or GED required.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.
• This position requires a visual acuity screening.
• This position requires cleanroom gown certification.