- Perform QC testing in a cGMP lab for raw material release, final product/in process testing and process qualifications
- Conduct data analysis of testing results, and review data obtained for compliance to SOP and specification.
- May transfer methodology from other groups and may maintain complex equipment.
- Will author reports, SOPs and other documentation for quality testing.
- Provide training and technical leadership to less experienced staff.
- Participate in laboratory investigations and non-conformance deviations.
- Perform finished product review and lot release.
- Schedule laboratory activities.
- Manage departmental projects.
- Practice safe work habits and adheres to company safety procedures and guidelines.
- Serve as the laboratory point of contact for less experienced staff when management is not present (weekends, holidays)
- Participate in the execution of corrective and preventative action plans as well as the initiation and follow through for change controls.
- Master core responsibilities of an Analyst II.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make the company a great place to work, and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Bachelor's Degree or equivalent in a scientific discipline and 6 +years of cGMP quality experience, or comparable laboratory experience.
- Existing QC analyst II demonstrating mastery of the Analyst Senior competencies.
- Must have experience as a technical leader in a strong team environment and work independently to successfully balance short and long term project objectives.
- Experience with Deviation Management and Change Control.
- Experience with complex analytical methods. E.g. PCR based methodology or cell culture methods.
- Experience with assay/equipment validations/transfers.
- Experience with microbiological testing or environmental monitoring.
- Excellent communication skills, verbal and non-verbal desired.
- Excellent technical writing and investigational skills.
- Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.
- Ability to lift 40 lbs.
- Requires working one day per weekend.
- Rotating holiday coverage.