Laboratory Quality Assurance
Primera Analytical Solutions Corp, founded in 2002, is a contract research organization (CRO) that provides analytical, bioanalytical, formulation development, and clinical trial services to pharmaceutical, biotechnology, and other life science industries. We have an excellent tracking record with FDA inspections and successfully accomplished the analytical work for many ANDAs and NDAs.
Responsibilities:
- Perform audits of laboratory data packages.
- Perform routine laboratory responsibilities such as sample coordination, lab equipment maintenance, document management, inventory control, and reconciliation of sample requests/documents as needed.
- Assure adherence of acceptable cGMP/GLP practices by staff.
- Keep Quality Management informed of quality issues. Ensure compliance with applicable regulatory guidelines.
Qualifications:
- High School degree required, advanced degree in a scientific discipline, such as Chemistry, Biology, Food Science, and Chemical Engineering preferred.
- 0 – 3 years pharmaceutical experience.
- An understanding of cGMP/GLP requirements and other policies/regulations preferred.
- Attentive to detail.
- Excellent teamwork and communication skills, able to work in a cross-functional environment.
- Good computer skills, profound knowledge with Microsoft Word, Excel, and PowerPoint.
Primera values its staff by creating an environment that supports learning and career development. Employees have the opportunity to work with talented and energetic teams, expand their skill sets, and be part of a team that supports many pharmaceutical companies in providing drugs to consumers.
- Benefits include Medical, Dental, Vision, and 401K matching plan
- Including H1B Visa and Green Card Sponsorship