Sample Management Associate (Biowork Certification) / Pharma Manufacturing from Pioneer Data Systems
Sanford, NC 27330
About the Job
Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Sample Management Associate to join their expanding team.
Position Details:
- Job Title: Sample Management Associate (Biowork Certification) / Pharma Manufacturing
- Duration: 18 months contract, extendable up to 36 months
- Location: Sanford, NC
Note:
- The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
- You may participate in the company group medical insurance plan
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:
- FDA / GMP Compliance
- GDP Documentation
Preferred Skills:
- Labware LIMS
- Sample management and handling
Interview Process:
- 1:1 Teams (Camera On)
- 2nd Shift
- 3p-11:30p M-F
Minimum Education:
- Bioworks Certification with 2+ years of experience. Or
- Bachelor's