2nd Shift
3p-11:30p M-F
Job Description: 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.
Hard Skills:
1. FDA / GMP Compliance
2. GDP Documentation
Preferred Skills:
1. Labware LIMS
2. Sample management and handling
