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Position Details:
Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Sample Management Associate to join their expanding team.
Job Title: Sample Management Associate / Pharma Manufacturing (3rd Shift)
Duration: 13 months contract, extendable up to 36 months
Location: Sanford, NC
3rd Shift: 10:45 PM - 7:15 AM
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:
Sample Management Associate
Summary:
The Sample Management Associate will support the Quality Operations department by performing Quality Control activities associated with clinical and/or commercial products, raw materials, validation, and stability.
The Sample Management Associate's 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 such as pick up from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to the appropriate lab, etc.
Responsibilities:
Acts safely and follows all EH&S safety requirements for site and QC laboratories with sufficient depth of knowledge within their scientific discipline and previous area of experience with 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 the 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 the team
Increased ability to communicate effectively with good interpersonal skills; establish relationships within Quality lines
Qualifications:
Bioworks Certification with a minimum of 1+ years of experience
Experience with Labware LIMS
Sample management and handling experience
FDA / GMP Compliance experience
GDP Documentation experience
Good Manufacturing Practices (cGMP) experience
Microsoft OfficeTM experience specifically Word and Excel,
Experience with analytical techniques and instrumentation
Lean Six Sigma concepts and Lean Labs experience
Location:
This is an onsite role in Sanford, NC
Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Sample Management Associate to join their expanding team.
Job Title: Sample Management Associate / Pharma Manufacturing (3rd Shift)
Duration: 13 months contract, extendable up to 36 months
Location: Sanford, NC
3rd Shift: 10:45 PM - 7:15 AM
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:
Sample Management Associate
Summary:
The Sample Management Associate will support the Quality Operations department by performing Quality Control activities associated with clinical and/or commercial products, raw materials, validation, and stability.
The Sample Management Associate's 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 such as pick up from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to the appropriate lab, etc.
Responsibilities:
Acts safely and follows all EH&S safety requirements for site and QC laboratories with sufficient depth of knowledge within their scientific discipline and previous area of experience with 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 the 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 the team
Increased ability to communicate effectively with good interpersonal skills; establish relationships within Quality lines
Qualifications:
Bioworks Certification with a minimum of 1+ years of experience
Experience with Labware LIMS
Sample management and handling experience
FDA / GMP Compliance experience
GDP Documentation experience
Good Manufacturing Practices (cGMP) experience
Microsoft OfficeTM experience specifically Word and Excel,
Experience with analytical techniques and instrumentation
Lean Six Sigma concepts and Lean Labs experience
Location:
This is an onsite role in Sanford, NC
