Sample Coordinator

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 OfficeTM 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

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”