Quality Assurance Auditor I

Quality Assurance Auditor - 1st, 2nd, & 3rd Shift Opportunities (differential will be applied to 2nd and 3rd shifts)

How this position makes a difference: 

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.  
• Other duties as assigned or required.  

 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. 
• Ability to be flexible in work hours.  
• Ability to provide motivational support.  
• Ability to maintain a professional, positive attitude at all times.  
• 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.  
• Ability to work in a fast-paced environment.  
• Ability to detail and coordinate various activities simultaneously. 
• Ability to complete assigned tasks   

 About Us: https://www.steri-pharma.com

Notice of Employee Rights, Protections, and Obligations under Labor Law Section 740: https://dol.ny.gov/system/files/documents/2022/02/ls740_1.pdf

EEOC 'Know Your Rights' Poster: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

Employee Rights Under the Polygraph Protection Act: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf