Quality Assurance Specialist
The Quality Assurance (QA) Specialist is responsible for providing QA input and guidance for Manufacturing, Supply Chain, Quality, and R&D activities. The QA Specialist will perform all responsibilities in accordance with company policies, procedures, global regulations and safety requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Review and approve documents in support of manufacturing and quality testing including batch records, test data, and receiving inspection.
2. Review and assess non-conformances; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
3. Review, approve and facilitate change controls including tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
4. Support remediation efforts to negative quality trends.
5. Interact professionally with all departments to effectively implement and maintain Quality Systems.
6. Assist in document creation, including Standard Operating Procedures, protocols, batch records, and reports.
7. Perform Internal Audits, External Audits and Data Audits, as needed.
8. Ensure operations compliance – which includes support of implementing procedures that enhance GMP, GLP and safety.
9. Support existing and/or develop and implement new programs/processes designed to drive continuous improvement.
10. Provide on-the-floor QA oversight of manufacturing operations.
11. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
12. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
13. Perform other quality assurance functions as necessary, with appropriate training.
Ability and willingness to travel up to 10% of the time between facilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and three to five years GMP related experience in biopharmaceutical/pharmaceutical or related industry with direct Quality experience; or equivalent combination of education and experience. Familiarity with pharmaceutical manufacturing processes, 21CFR210/211/820/11.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel.
• Detail oriented and very organized
• Strong verbal and written communication skills
• Ability to prioritize and handle multiple tasks simultaneously
• Adaptable to change in the work environment
• Ability to work in a fast-paced environment
• Ability to work in a team environment, as well as independently
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.