Clinical-Scientific - Quality Assurance Specialist - Pioneer Data Systems
Sanford, NC 27330
About the Job
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 (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:
Sample Management Associate
Summary:
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.
Responsibilities:
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
Support the Quality Operations department by performing quality control activities associated with clinical and/or commercial products, raw materials, validation, and stability
Perform GMP tasks associated with maintaining compliant quality control and stability laboratories
Provide sample management support for quality control
Create, review, and approve documentation
Support the sample management process for quality control (pick up from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to appropriate lab, etc)
Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching
Makes good decisions based on knowledge of quality systems/technical experience and work is accurate with little to no errors
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
Qualifications:
Bioworks Certification with a minimum of 2+ years of relevant experience OR Bachelor's degree in a relevant field
FDA/GMP compliance experience
GDP documentation experience
Labware LIMS and sample management and handling experience preferred
Experience and proficiency with Microsoft Office applications, specifically Word and Excel
Experience with analytical techniques and instrumentation
Experience with Lean Six Sigma concepts and Lean Labs
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
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)
Increased ability to communicate effectively with good interpersonal skills; establish relationships within Quality lines
Location:
This is a fully onsite role in Sanford, NC
Monday - Friday 2nd shift - 3:00 PM - 11:30 PM
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 (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:
Sample Management Associate
Summary:
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.
Responsibilities:
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
Support the Quality Operations department by performing quality control activities associated with clinical and/or commercial products, raw materials, validation, and stability
Perform GMP tasks associated with maintaining compliant quality control and stability laboratories
Provide sample management support for quality control
Create, review, and approve documentation
Support the sample management process for quality control (pick up from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to appropriate lab, etc)
Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching
Makes good decisions based on knowledge of quality systems/technical experience and work is accurate with little to no errors
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
Qualifications:
Bioworks Certification with a minimum of 2+ years of relevant experience OR Bachelor's degree in a relevant field
FDA/GMP compliance experience
GDP documentation experience
Labware LIMS and sample management and handling experience preferred
Experience and proficiency with Microsoft Office applications, specifically Word and Excel
Experience with analytical techniques and instrumentation
Experience with Lean Six Sigma concepts and Lean Labs
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
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)
Increased ability to communicate effectively with good interpersonal skills; establish relationships within Quality lines
Location:
This is a fully onsite role in Sanford, NC
Monday - Friday 2nd shift - 3:00 PM - 11:30 PM
Source : Pioneer Data Systems