The Quality Control Analyst (QC III) will be primarily responsible for cell culture and cell bank development, as well as molecular release testing of GMP products. The analyst will support QC testing for all final drug products, internal and external department test request, and stability studies at the Worcester MA facility. Testing will include, but not limited to, qPCR, ddPCR, cell count/viability, flow cytometry and cell culture release testing. The analyst will also work with other departments on new assays being transferred to QC, writing SOPs and reports that will incorporate scientific studies, method validation and investigation activities.
Job Level 3:
An experienced analyst with a full understanding of area of specialization; resolving a wide range of issues and contributing to the success of the companies’ objectives in creative ways.
Works on problems of diverse scope, where analysis of data requires evaluation of multifaceted variables. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Effectively networks within functional area and creates formal networks involving coordination among various departments.
· Developing and overseeing the QC cell bank, to ensure high quality cell lines are made to support release testing.
· Occasionally support testing that may be required to be performed on a weekend.
· Conducting molecular release test (FLOW Cytometry, DNA Extraction, ddPCR, etc.) and provide EM (plate reads, visual inspection etc.) support as needed.
· Assisting in the transfer of assays from the Analytical Development Lab to the QC Lab.
· Authoring and reviewing laboratory specific processes and procedures.
· Completing document change orders as well as participate in the investigation and resolution of Deviations and Out of Specification (OOS).
· Ordering and maintaining all reagents for cell bank development, training and release testing.
· Assisting in cell culture/cell bank onboarding and OJT of analysts.
Education & Qualifications:
Education: Bachelor’s degree in Chemistry, Biological Sciences or related field, or equivalent combination of education and work experience.
· 5 years minimum in Quality Control, Quality Assurance, Quality Control, or other compliance role.
Skills and Abilities:
· Ability to act independently to determine methods and procedures on new or special assignments. May supervise the activities of others (Team Lead)
· Industry experience with analytical methods, such as flow cytometry, imaging cytometry, qPCR, qRT-PCR, ELISA, cell-based potency assays.
· Working knowledge of FDA cGMP requirements.
· Strong interpersonal and communications skills.
· Attention to detail, organizational skills, and ability to multi-task in a dynamic environment.
· Ability to identify opportunities for process improvements and communicate appropriately.