Position Details

The Quality Assurance Specialist is an integral part of our Quality Assurance team responsible for our Phibro Vaccines Omaha (PVO) office in Omaha, NE. The Quality Assurance Specialist issues, reviews, makes edits to, and maintains completed documents, , performs internal auditing and assists in customer audits, , maintains deviation and CAPA logs, verifies accuracy of outgoing shipments of finished products, manages validation/certification/calibration of equipment, assists in maintenance of the Master File System, manages control and issuance of labels, and maintains employee training logs. Specific responsibilities include but are not limited to:

Key Responsibilities

• Set up and manage paper or electronic filing systems, recording information, updating paperwork, and maintaining QA documents and software.
• Complete forms in accordance with company procedures
• Maintain, file, archive, and retrieve documents, records and reports.
• Communicate with employees, and other individuals to answer questions, disseminate or explain information, and conduct internal audits.
• Compute, record, write protocols, proofread data and other information, such as Standard Operating Procedures (SOP’s), Manufacturing and Testing Protocols and Corrective and Preventative Action (CAPA) records or reports, Employee training logs, etc...
• Read and analyze incoming documents, assessment questionnaires, memos, submissions, and other data to determine their significance, and plan document control.
• Other duties as assigned.

Key Competencies

Collaborative

Communicating Effectively

Delivering High Quality Work

Following Policies and Procedures

Managing Time

Prioritizing and Organizing Work

Skills

Extremely high level of attention to detail and high standard of quality.

Must be accurate, detail-oriented and thorough.

Advanced organizational skills.

Interpersonal skills sufficient to communicate verbally and in writing with others in an objective and cooperative manner.

Proven ability to work effectively in a team environment.

Proficiency in Microsoft Office Products

Must be proficient using Email, phones, cell phones, and office equipment.

Education & Experience

• Education and/or Experience: Requires an Associate’s Degree preferably in Biological Science field; and/or four+ years’ experience in Quality Assurance operations. USDA regulation knowledge a plus.
• Reasoning Ability: Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Must be able to make decisions on routine matters. Ability to define and solve practical problems, collect data, establish facts and draw valid conclusions.
• Decision Making Responsibilities: Must work primarily in a worker capacity in a team environment. Have informal contact daily with management. Good organizational and writing skills necessary to track and document.
• Skills: Ability to read, analyze, and interpret in the English language correspondence, general business reports, professional journals, technical procedures, and reports. Ability to apply mathematical formulas to practical situations with laboratory work including conversions and volume measurements of dosages. It also requires computer/software utilization.
• Work Environment: May need to move boxes; 30lbs to 50 lbs. Office and Lab

Physical Requirements

Required to sit frequently

Required to stand frequently

Required to talk or hear frequently

Required to walk frequently