Quality Assurance Auditor I

Quality Assurance Auditor 1st/2nd/3rd Shift

This position performs critical inspection duties such as line coverage, audit reviews, and monitoring charts. Position is required to complete all required paperwork and data entry specific to quality assurance monitoring.

Duties & Responsibilities:

• Perform line checks including in process testing, component verification, bar code operation, sample review, aseptic monitoring and end item inspection.
• Complete line clearance inspections, including reviews of area logs for proper documentation prior to lot processing. Check in all components prior to use for production.
• Review and approve production records along with associated production paperwork prior to issuance. Ensure all calculations are correct.
• Chart reviews, log reviews, product reviews, document reviews.
• Perform batch record reviews for accuracy and compliance to company procedure.
• Oversee the documentation of production interventions as needed.
• Area purges (packaging and/or vial wash).
• Shelf reserve sampling, reviews, TRRs and documentation.
• Successfully complete Manual Inspection Qualification for vial inspections.
• Attends meetings as required or requested.
• Promote a safe and harmonious work environment.
• Maintain compliance with SOPs, GMPs, and all company policies.

Requirements:

• Associates degree from a regionally accredited institution in science or related field.
• Minimum 1 year quality assurance experience in pharmaceutical or other highly regulated industry.
• Knowledge of general computer functions such as Microsoft Office programs, spreadsheets, etc.
• Knowledge in quality auditing practices.
• Knowledge and understanding of processes relevant to quality compliance of the manufacturing and production of regulated products, regulatory and development processes, regulatory cGMP requirements for pharmaceuticals, regulatory entity inspections requirements, regulatory guidance documents.
• Knowledge of HACCP and other audit schemes.
• Skill in handling several projects or tasks at the same time, or within a given time frame.
• Advanced Problem Safety Sensitivity; the ability to recognize a safety issue or potential safety issue.
• Skill to use time management techniques in personal daily tasks and that of others.
• Skill in quality and compliance vigilance.
• Ability to inspect the work of others and coach performance in line with company standard operating procedures.
• Ability to apply critical thinking.
• Advanced interpersonal and communication skills.
• Ability to effectively articulate and present the company’s quality strategy to our employees, senior management, regulatory bodies and customers.
• Advanced project management and documentation skills.
• Ability to use training/instructional methods and procedures appropriate for the situation and audience.
• Ability to instruct/teach one on one on how to perform functions.
• Ability to trust, develop, maintain, and strengthen partnerships with others inside the organization who can provide information, assistance, and support.
• Ability to work with minimal supervision and lead by example.
• Ability to communicate with coworkers, management team members, and other individuals in a courteous and professional manner.

Physical Demands:

• Seeing: Must be able to read reports and use computer 75-100% of time
• Hearing: Must be able to hear well enough to communicate with coworkers 75-100% of time
• Standing/Walking/Mobility: Must be able to stand to open files and operate office equipment; mobility between departments and attend meetings of coworkers and management 75-100% of time
• Climbing/Stooping/Kneeling: Must be able to climb, stoop, or kneel to perform routine tasks within the scope of job 25-49% of time
• Lifting up to 40 lbs./ Pulling/Pushing: within the scope of job 25-49% of time
• Touching/Grasping/Feeling: Must be able to write, type, and use office equipment; along with handling material and equipment 75-100% of time