Quality Assurance Auditor
Laurinburg, North Carolina
Huvepharma, Inc. is seeking an experienced Quality Assurance Auditor to plans, lead, and performs QA functions to assure the quality of the company’s products and services.Qualifications:
- Bachelor’s Degree in Microbiology, Biology, Immunology or related life science
- Requires at least 5-10 years’ experience in a quality assurance environment directly engaged in related research, licensing, and/or commercialization of biological products.
- In depth knowledge of federal regulations within a USDA environment
- Must have strong team leadership skills and communicate effectively with people and team members at all levels of the organization.
- Excellent written and verbal skills to be able to reinforce requirements in a positive and professional way to colleagues at all levels within the organization
- Good understanding of the technology employed within the lab and production areas
- Strong focus on attention to detail
- Keen attention to due dates and deadlines to meet USDA requirements and production schedule
- Ability to identify complex problems and review related information to develop and evaluate options and implement solutions
- Must be proficient in the use of MS Office tools including MS Access and use of other databases
- Responsible for the final review and approval of final project reports, standard operating procedures, specifications and other documentation that impact quality
- Responsible for review of manufacturing and testing records to ensure compliance to internal procedures, and USDA approved documents for release of product for distribution
- Participate in material review board meetings and follow up to action items
- Responsible for scheduling and conducting internal audits of laboratory, manufacturing, facility, document control functions to ensure compliance with SOPs and appropriate regulations and follow-up to ensure compliance issues are addressed.
- May assist in scheduling and ensuring audits of external vendors.
- Responsible for maintaining personal training on applicable documents and relevant procedures including safety and biosafety training and for ensuring appropriate documentation of personal training.
- Develop and upgrade QA systems to assure compliance with relevant regulations.
- Assist with writing, verification and QA approval of deviations and investigations as necessary for product release. Recommend and follow up of corrective and preventative actions.
- Track status and closure of manufacturing investigations, customer complaints, CAPA’s and effectiveness.
- Responsible for notifying management of delays that prevent timely review or of missed deadlines because of compliance issues. Establish or adjust work procedures to meet deadlines.
- May oversee other QA staff that require immediate supervision.
- Perform complex compliance problem solving on diverse projects. Exercise judgment in selecting and recommending procedures for obtaining solutions to problems. Assist personnel with compliance problem solving.
- Determine how time, resources and available personnel can be used most effectively to achieve QA and company goals.
- Responsible for the timely release of received operational materials requiring review to ensure the received materials are within the acceptable quality standards for use.
- Assist in USDA licensed facility inspections
Please send a resumé to firstname.lastname@example.org