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About the Role

This position performs critical inspection duties such as line coverage, audit reviews, and monitoring charts. The role requires completion of all required paperwork and data entry specific to quality assurance monitoring.

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.
• Perform chart reviews, log reviews, product reviews, and document reviews.
• Perform batch record reviews for accuracy and compliance to company procedure.
• Oversee the documentation of production interventions.
• Perform area purges (packaging and/or vial wash).
• Conduct shelf reserve sampling, reviews, TRRs and documentation.
• Successfully complete Manual Inspection Qualification for vial inspections.
• Attend meetings as required or requested.
• Promote a safe and harmonious work environment.
• Maintain compliance with SOPs, GMPs, and all company policies.
• Perform 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 and spreadsheets.
• Knowledge in quality auditing practices.
• Knowledge and understanding of processes relevant to quality compliance of regulated product manufacturing and production.
• Knowledge of regulatory and development processes.
• Knowledge of regulatory cGMP requirements for pharmaceuticals.
• Knowledge of regulatory entity inspections requirements.
• Knowledge of regulatory guidance documents.
• Knowledge of HACCP and other audit schemes.
• Skill in handling multiple projects or tasks simultaneously.
• 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 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 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.

Skills

• Microsoft Office programs
• Spreadsheets
• Quality auditing practices
• HACCP
• Project management
• Documentation

Location

• Onsite

Work Type

• Full-time

Experience Level

• Minimum 1 year

Education Level

• Associates degree

About the Company

• https://www.steri-pharma.com

Equal Opportunity

• 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