Under general supervision, ensures compliance to cGMP regulations in a pharmaceutical manufacturing area including all documentation. Essential functions include: - Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensures compliance with all Company policies and procedures, including safety rules and regulations.
- Facilitates communication between departments to ensure efficient flow of QA activities related to the production schedule, including but not limited to document issuance, production room audits, AQL sampling/testing, collection/delivery of samples, ERP activities, expiration date monitoring, intermediate product review/releases and finished product review.
- Interfaces with manufacturing, warehouse, QC, and materials management to ensure timely and accurate shipment of products.
- Reviews data from Quality Control, including Swab Data.
- Prepares, revises, and verifies SOPs and forms.
- Monitors environment as needed.
- Maintains Quality Assurance documentation files, databases, and logs.
- Assists in preparing capacity planning data.
- Monitors training for compliance.
- Prepares and conducts GMP training to Manufacturing and Quality Assurance staff as needed.
- Manages Retain samples.
- Right the First Time monitoring.
- Maintains effective Writing skills in conducting change control, investigations, and CAPA related activities.
- Performs related duties as assigned.
Three (3) years pharmaceutical quality assurance auditing experience or an equivalent combination of education and experience.Knowledge of:
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), DEA (Drug Enforcement Agency), European Medicines Agency (EMA) and other regulatory requirements.
- Principles of auditing and performance evaluations.
- AQL sampling and inspection principles and techniques.
- Principles of mathematical and statistical computation and analysis.
- Business, scientific and personal computer hardware and software applications.
- Business English usage, spelling, grammar and punctuation.
- Pharmaceutical principles, practices and their applications.
- Current Company policies, practices and procedures, including safety rules and regulations.
Note: Work Schedule; Fri-Sun, every other Th, 6:00 p.m. - 6:30 a.m.
*Position does not include a relocation benefit.
Bachelor’s Degree in Science or related field from an accredited college or university.*LI-WK1