JOINN Biologics is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies.  JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry. 

SUMMARY:

• We are searching for a highly motivated Quality Control Analyst who preferably has a minimum of 2 years of experience working in cGMP quality control laboratory environment with expertise in wet and protein chemistry to join our team. 
• The candidate will be responsible for the qualification and execution of analytical laboratory tests and evaluations of product performance and processes in the Quality Control Department, in accordance with approved methodologies, policies, and associated regulations.

DUTIES AND RESPONSIBILITIES include but are not limited to:

• Perform and review assays, under supervision, for protein and wet chemistry tests including but not limited to: pH, conductivity, TOC, Osmolality, UV-VIS, HPLC, Capillary Isoelectric Focusing, SDS-PAGE, qPCR, ELISA, etc.
• Comply with cGMPs, SOPs, GLPs, safety requirements, and all company policies.
• Write and revise SOPs, technical protocols, and reports, when needed.
• Perform validations, studies, or transfers of new analytical methods and modifications to current methods in accordance with applicable policies or guidelines.
• Generate highly compliant and reliable test results via documentation and by following cGMP principles.
• Train and mentor other analysts in the quality control department, such as performing laboratory procedures and assays.
• Evaluate test data against defined criteria and specifications.
• Identify and troubleshoot equipment and method issues.
• Participate in out-of-specification and deviation investigations and recommend corrective actions
• Establish and maintain a safe and inspection-ready laboratory working environment.

Required Qualifications:

• Minimum of BS/BA degree and 4-5+ years working in a cGMP environment.
• Familiarity with relevant and current FDA, USP, EP, 21CFR, ICH guidelines and regulations.
• Demonstrated knowledge of method development and qualifications.
• Strong technical writing and analytical skills.
• Excellent written, verbal, communication and interpersonal skills.
• Ability to manage multiple projects in a fast-paced environment.
• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to follow written instructions and to perform tasks with minimal supervision.
• Ability to work independently as well as in a team environment.

Preferred Qualifications:

• Experience working in a Quality Control work environment, preferably in the pharmaceutical industry with knowledge of cGMPs or ISO regulations is desired.
• MS with 3+ years related working experience.