Quality Assurance Associate
This position has the overall responsibility to evaluate and review laboratory, manufacturing, clinical data, QA material release and all associated procedures to assure compliance with applicable regulations and internal procedures and policies as dependent upon site.
EDUCATION AND EXPERIENCE
- Associates or Bachelor’s Degree in Microbiology, Biology, Immunology, or related life science, plus 3 years’ related experience
- Prior experience related to research, licensing, and/or commercialization of biological products is strongly preferred
TECHNICAL SKILLS REQUIREMENTS
- Knowledge and understanding of USDA regulations
- Self-starter with ability to work independently
- Good documentation skills
- Keen attention to detail
- Keen attention to due dates and deadlines to meet production schedules
- Basic understanding of the technology employed within production and the lab
- Ability to use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
- Ability to communicate verbally and in writing to reinforce requirements in a positive and professional way to colleagues at all levels within the organization
- Ability to identify complex problems and review related information to develop and evaluate options and implement solutions
- Must have strong team participation skills and ability to communicate effectively with people and team members at all levels of the organization
- Be proficient in the use of MS Office software packages
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The employee is occasionally exposed to a variety of extreme conditions. The noise level in the manufacturing environment can be loud.
Ability to travel on occasion between sites or as necessary for vendor audits.
POSITION RESPONSIBILITIES (dependent upon site)
- Responsible for monitoring production, clinical and laboratory activities to ensure compliance with SOP’s, Outlines of Productions, and other applicable documents.
- Responsible for review and approval of production and testing records, reports, procedures, specifications, and other documentation to ensure accuracy to data and compliance to internal procedures and USDA approved documents for release of products for distribution or pre-license studies.
- Scheduling and conducting internal audits of production, laboratory, facility and document control functions to ensure compliance with SOP’s and appropriate regulations and follow up to ensure compliance issues are addressed.
- Responsible for annual review or change control of approved regulatory documents
- May schedule, coordinate, participate and keep record of audits, both physical on-site and questionnaire format, of external vendors.
- May assist or be responsible for submission of APHIS Form 2008 on CVB portal for product release.
- May assist or be responsible for QA release and disposition of raw materials in a timely manner.
- May provide back up to Document Control activities including issuance, preparation, revision and maintenance of SOPs, Specifications, PWS and other DC documents and labels.
- May assist or be responsible for archival of laboratory, clinical and production generated raw data.
- May assist with entering training records in database and maintenance of training files.
- May assist or lead Quality Systems training for employees.
- Assist with deviations and investigations and recommendations and follow-up for corrective and preventative actions.
- May assist or lead in Equipment Change Control and other tasks to ensure compliance with equipment.
- Maintains current personal training on applicable documents and relevant procedures.
- Responsible for notifying QA Manager and site management of delays that prevent timely review or of missed deadlines because of compliance issues.
- Assists personnel with compliance problems solving.
- Participates in the development and upgrading of Quality systems to assure compliance with relevant regulations.
- Assists personnel with compliance problem solving.
- Customer Focus
- Integrity, Safety & Compliance
- Achieves Results
- Quality Orientation
- Written/Oral Communication
- Critical Thinking
Huvepharma will not accept unsolicited resumes from Staffing Agencies, Placement Services or Professional Recruiters.