Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, or similar
In some cases, an equivalency, consisting of a combination of appropriate
education, training and/or directly related experience, will be considered
sufficient for an individual to meet the requirements of the role.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years')
Minimum 5 years of experience in biologics, biotechnology, pharmaceutical manufacturing, quality control, quality systems, supplier quality, or raw materials management.
Demonstrated experience authoring specifications within a GMP-regulated environment.
Experience reviewing Certificates of Analysis, supplier quality documentation, and technical data packages.
Strong understanding of GMP regulations and ICH guidelines
Experience with electronic quality systems, document management systems, ERP systems, and/or LIMS.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
