Sample Management Associate - 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 Manufacturing Quality Associate to join their expanding team.
Job Title: Manufacturing Quality Associate (Biowork certification, LIMS) / Pharma Industry
Duration: 12 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.
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)
Responsibilities:
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 sample managment process for quality control (pick up from manufacturing, maintain chain of custody in LIMS, aliquoting/delivering samples to appropriate labs, etc.)
Act safely and follow 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
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
Apply discipline's principles and appropriate procedures to design and execute work against work group goals
Responsible for personal timelines delivery and seeks advice if conflicts arise.
Interact with business lines and shares information with team
Qualifications:
Bioworks Certification with a minimum of 1+ years of experience required
Sample management / handling experience
Knowledge of Good Manufacturing Practices (cGMP)
Laboratory Information Management System (LIMS) experience
Proficient in the use of Microsoft Office applications, specifically Word and Excel
Experience with analytical techniques and instrumentation
Knowledge of Lean Six Sigma concepts as well as Lean Labs
GDP documentation experience
Ability to follow written procedures and learn from hands on training
Capability of solving complex mathematical and situation-dependent problems
Aptitude for good decision-making based on procedures, guidance, and experience
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
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)
Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments
Increased ability to communicate effectively with good interpersonal skills; establish relationships within Quality lines
Hours:
Training schedule will be normal hours Monday - Friday; once training is completed, schedule will shift to Wednesday - Sunday 7:00 AM - 3:30 PM
Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Manufacturing Quality Associate to join their expanding team.
Job Title: Manufacturing Quality Associate (Biowork certification, LIMS) / Pharma Industry
Duration: 12 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.
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)
Responsibilities:
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 sample managment process for quality control (pick up from manufacturing, maintain chain of custody in LIMS, aliquoting/delivering samples to appropriate labs, etc.)
Act safely and follow 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
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
Apply discipline's principles and appropriate procedures to design and execute work against work group goals
Responsible for personal timelines delivery and seeks advice if conflicts arise.
Interact with business lines and shares information with team
Qualifications:
Bioworks Certification with a minimum of 1+ years of experience required
Sample management / handling experience
Knowledge of Good Manufacturing Practices (cGMP)
Laboratory Information Management System (LIMS) experience
Proficient in the use of Microsoft Office applications, specifically Word and Excel
Experience with analytical techniques and instrumentation
Knowledge of Lean Six Sigma concepts as well as Lean Labs
GDP documentation experience
Ability to follow written procedures and learn from hands on training
Capability of solving complex mathematical and situation-dependent problems
Aptitude for good decision-making based on procedures, guidance, and experience
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
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)
Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments
Increased ability to communicate effectively with good interpersonal skills; establish relationships within Quality lines
Hours:
Training schedule will be normal hours Monday - Friday; once training is completed, schedule will shift to Wednesday - Sunday 7:00 AM - 3:30 PM
Source : Pioneer Data Systems