Quality Assurance Auditor I

Steri-Pharma; City of Syracuse (NY); Sur place; USD 52 000 - 78 000; Plein temps

Résumé du poste

Thisiscny is seeking a Quality Assurance Auditor for 1st/2nd/3rd shifts to perform line checks, audits, and maintain QA documentation in a regulated pharmaceutical setting.

The role requires an associate degree in science, at least one year of QA experience, familiarity with GMP, HACCP, and cGMP standards, and strong attention to detail and communication.

Qualifications

• Associates degree in science or related field.
• Minimum 1 year QA experience in pharmaceutical or regulated industry.
• Knowledge of Microsoft Office.
• Knowledge of quality auditing practices.
• Understanding of cGMP requirements for pharmaceuticals.
• Knowledge of HACCP and audit schemes.
• Ability to manage multiple projects or tasks.
• Advanced safety awareness and issue recognition.

Responsabilités

• Perform line checks including in-process testing and end item inspection.
• Complete line clearance inspections and verify documentation prior to lot processing.
• Review and approve production records and calculations.
• Chart reviews, log reviews, product reviews, and document reviews.
• Perform batch record reviews for accuracy and compliance with procedures.
• Oversee documentation of production interventions as needed.
• Promote a safe and compliant work environment and SOP adherence.

Connaissances

QA auditing

GMP knowledge

HACCP

MS Office

Critical thinking

Communication skills

Time management

Regulatory compliance

Formation

Associate degree in science

Description du poste

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

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.

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

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