160 Pharma Dr Morrisville, NC 27560
The Quality Assurance department plays a necessary role in the daily operations of the facility. The primary function of the department is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. The department is entirely separate from and independent of the personnel engaged in the direction and conduct of the project. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material and finished-product release.
As an entry level position, the auditor is able to perform routine auditing of pharmaceutical projects, using established procedures. This position requires moderate independent judgment with direct supervision. The work is routine and well defined. Discuss actions to be taken with supervisor before resolving issues. As an experienced position the auditor can work under general supervision and is able to perform more complex auditing of pharmaceutical projects and systems using established procedures. Independently performs routine work with progressively more involvement in recommendations for the improvement of the department. Subsequently, may require direct supervision under non-routine circumstances. Will make judgments on observations with limited supervisory review. Position requires some degree of initiative to resolve problems. The work is routine to moderately complex but covered by well-defined policies and procedures. Discusses actions to be taken before resolving routine problems. Comply with divisional and site Environmental Health and Safety requirements. Specific Duties, Activities, and Responsibilities of time. Audit a variety of methodologies as applied to various stages of pharmaceutical development. Verify accurate transcription of raw data into reports. Audit above testing for compliance to all applicable SOPs and regulatory requirements. Discuss issues with lab staff as discovered during final report auditing, laboratory walkthroughs, or other internal audits. Archive study phase documentation in a timely manner. Identify potential compliance issues and takes corrective measures to prevent them, participating on assigned teams as required. All other duties as assigned.
Education and Experience:
BS in Micro or Biology or closely related physical science from a four-year college/university or equivalent education and job experience 1-2 years related experience and/or training is required
Knowledge, Skills and Abilities:
- The employee must have a good understanding of chemistry/lab practices and be able to function independently with supervision
- Good communication and organizational skills are required
- Requires knowledge of cGMP, GLP, ICH, and USP regulations or guidelines
- Requires contact with multiple departments and on occasion with customers
- May require formal presentation to co-workers
- Usually supplies and seeks information where exceptional tact and courtesy is needed
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.