Summarize the primary purpose & key accountabilities of the job.
The position will support the Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, validation, and stability. Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; providing sample management support for QC; and creating, reviewing and approving documentation. Responsible for supporting the sample management process for QC (pick up from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to appropriate lab, etc)
At a minimum, the individual should be considered able to demonstrate the following: • Acts safely and follows all EH&S safety requirements for site and QC laboratories sufficient depth of knowledge within their scientific discipline and previous area of experience good written and verbal communication techniques. • Ability to follow written procedures and learn from hands on training. • Capability of solving complex mathematical and situation dependent problems. • Ability to receive feedback and take accountability for actions and personal development. • Aptitude for good decision making based on procedures, guidance, and experience. • Awareness to know their own limitations and seek senior scientist or management guidance when appropriate. • Desire to ensure correctness and accuracy in tasks and documentation, detail oriented. • Fitness of functioning as a team member and performing independent work with minor guidance. • Willingness to use personal skills and knowledge to achieve individual and company goals and objectives. • Understanding of own area of function and knowledge of other cross functional areas. • Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching. • Experience assisting with laboratory investigations to define root cause and assisting with validation protocol non-conformances method 1, yellow belt trained and/or understands use of tools and can apply them to solve issues (including technical issues).
understands the importance of feedback and receives feedback well from management and other colleagues. • Makes good decisions based on knowledge of quality systems/technical experience and work is accurate with little to no errors. • Recognizes the impact of procedural changes that may impact future quality tasks and decisions. • Applies discipline's principles and appropriate procedures to design and execute work against work group goals. • Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments. • Responsible for personal timelines delivery and seeks advice if conflicts arise. • Interacts with business lines and shares information with team. • Increased ability to communication effectively with good interpersonal skills; establish relationships within Quality lines.
Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.
Minimum Requirement: Bioworks Certification with 2+ years of experience.