Quality Assurance 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 Senior Quality Assurance Associate to join their expanding team.
Job Title: Senior Quality Assurance Associate / Pharma Manufacturing
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:
Quality Assurance Associate
Summary:
The site is a complex multi-product, multi-host biotech manufacturing site that manufactures clinical and commercial Vaccine and Gene Therapy products.
This position will support the Manufacturing Quality Assurance department by performing Quality activities associated with Gene Therapy (GTx) manufacturing operations.
You will be responsible for performing the following Quality Assurance (QA) responsibilities: batch disposition activities, manufacturing shop floor support including aseptic observations, investigation approval, change control approval, product and material release, complaints handling, Annual Product Record Reviews (APRR), and standard operating procedure and manufacturing batch record approval.
In addition, the position will be responsible for ensuring alignment with the Manufacturing Clinical and Commercial Quality Operations role.
As a GTx Quality Assurance Associate, your knowledge and skills will contribute towards the goals and objectives of the team.
This includes demonstrating independent decision-making in support of manufacturing. Strong communication skills are required to facilitate explaining difficult issues and achieving consensus between teams.
Responsibilities:
Execute real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and compliance
Review and Approval of SOPs, Batch Records, and Sample Plans
Perform and document Aseptic Observations of manufacturing processes (including Media Fills and Smoke Pattern Testing) and practices
Perform shop floor QA inspection and walk through for changeover and shutdown activities
Complete AQL for drug product filling operations
Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team
Suggest improvements and conduct continuous improvement activities
Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices
Provide Quality review and oversight of site cGxP documentation related to the operation of a Gene Therapy manufacturing facility to ensure compliance with global regulatory agencies and Pharmaceutical Quality Standards
Provide Quality support on the shop floor by maintaining presence during manufacturing operations, providing aseptic observations for drug product related processes (i.e. review in-process records, observe media fills, aseptic observation, airflow visualization review etc.), and conducting visual inspection for Drug Product operations
Acts as SME for department to support site audits/inspections
Interfaces with other parts of the organization such as Global Quality Operations groups and Client Research and Development groups
Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing
Provide manufacturing floor support that may include occasional weekends and second and/or third shift hours. Assess the operations executed for adherence to regulatory requirements, Quality Agreement requirements and Pharmaceutical expectations
Participates in activities/projects to support work group/project team goals
Approve SOPs, forms, protocols, change controls, and risk assessments (facilitator and/or team member).
Minimum Qualifications:
Applicant must have a minimum of 8+ years of relevant experience; OR an Associate's degree with a minimum of 6+ years of experience; OR a Bachelor's degree with a minimum of 3+ years of experience; OR a Master's degree with a minimum of 1+ years of experience
Knowledge of current Good Manufacturing Practices and applicable GxP regulations and standards
Proactive approach and strong critical thinking skills
Must be able to work in a team environment within own team and interdepartmental teams
Excellent communication, decision-making and interpersonal skills
Good working knowledge of Microsoft Excel and Word
Experience in Quality platforms (e.g LIMS, QTS, eQMS, SAP, DMS)
Demonstrate knowledge of and adherence to EH&S safety requirements for site
Display knowledge in cGXP, manufacturing operations, batch disposition, and Aseptic principles and concepts
Good foundation in general scientific practice and principles
Ability to organize and track status of assigned actions across multiple production areas
Ability to follow written procedures and learn from hands-on training
Preferred Qualifications:
Previous experience with a startup facility and developing Quality Operations processes is beneficial
Experience with Drug Substance and Drug Product clinical/commercial manufacturing preferred
Preferred experience with aseptic practices, investigations, and disposition activities
Willing to lead by example and be a collaborative and active listener
Effectively manages stressful situations, able to focus on tasks
Hours:
This is a fully onsite role in Sanford, NC
Work schedule is primarily first shift during weekdays, but may include weekends and second and/or third shift hours on occasion to support manufacturing operation activities
Minimal travel required for this position, no more than 5% traveling
Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Senior Quality Assurance Associate to join their expanding team.
Job Title: Senior Quality Assurance Associate / Pharma Manufacturing
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:
Quality Assurance Associate
Summary:
The site is a complex multi-product, multi-host biotech manufacturing site that manufactures clinical and commercial Vaccine and Gene Therapy products.
This position will support the Manufacturing Quality Assurance department by performing Quality activities associated with Gene Therapy (GTx) manufacturing operations.
You will be responsible for performing the following Quality Assurance (QA) responsibilities: batch disposition activities, manufacturing shop floor support including aseptic observations, investigation approval, change control approval, product and material release, complaints handling, Annual Product Record Reviews (APRR), and standard operating procedure and manufacturing batch record approval.
In addition, the position will be responsible for ensuring alignment with the Manufacturing Clinical and Commercial Quality Operations role.
As a GTx Quality Assurance Associate, your knowledge and skills will contribute towards the goals and objectives of the team.
This includes demonstrating independent decision-making in support of manufacturing. Strong communication skills are required to facilitate explaining difficult issues and achieving consensus between teams.
Responsibilities:
Execute real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and compliance
Review and Approval of SOPs, Batch Records, and Sample Plans
Perform and document Aseptic Observations of manufacturing processes (including Media Fills and Smoke Pattern Testing) and practices
Perform shop floor QA inspection and walk through for changeover and shutdown activities
Complete AQL for drug product filling operations
Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team
Suggest improvements and conduct continuous improvement activities
Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices
Provide Quality review and oversight of site cGxP documentation related to the operation of a Gene Therapy manufacturing facility to ensure compliance with global regulatory agencies and Pharmaceutical Quality Standards
Provide Quality support on the shop floor by maintaining presence during manufacturing operations, providing aseptic observations for drug product related processes (i.e. review in-process records, observe media fills, aseptic observation, airflow visualization review etc.), and conducting visual inspection for Drug Product operations
Acts as SME for department to support site audits/inspections
Interfaces with other parts of the organization such as Global Quality Operations groups and Client Research and Development groups
Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing
Provide manufacturing floor support that may include occasional weekends and second and/or third shift hours. Assess the operations executed for adherence to regulatory requirements, Quality Agreement requirements and Pharmaceutical expectations
Participates in activities/projects to support work group/project team goals
Approve SOPs, forms, protocols, change controls, and risk assessments (facilitator and/or team member).
Minimum Qualifications:
Applicant must have a minimum of 8+ years of relevant experience; OR an Associate's degree with a minimum of 6+ years of experience; OR a Bachelor's degree with a minimum of 3+ years of experience; OR a Master's degree with a minimum of 1+ years of experience
Knowledge of current Good Manufacturing Practices and applicable GxP regulations and standards
Proactive approach and strong critical thinking skills
Must be able to work in a team environment within own team and interdepartmental teams
Excellent communication, decision-making and interpersonal skills
Good working knowledge of Microsoft Excel and Word
Experience in Quality platforms (e.g LIMS, QTS, eQMS, SAP, DMS)
Demonstrate knowledge of and adherence to EH&S safety requirements for site
Display knowledge in cGXP, manufacturing operations, batch disposition, and Aseptic principles and concepts
Good foundation in general scientific practice and principles
Ability to organize and track status of assigned actions across multiple production areas
Ability to follow written procedures and learn from hands-on training
Preferred Qualifications:
Previous experience with a startup facility and developing Quality Operations processes is beneficial
Experience with Drug Substance and Drug Product clinical/commercial manufacturing preferred
Preferred experience with aseptic practices, investigations, and disposition activities
Willing to lead by example and be a collaborative and active listener
Effectively manages stressful situations, able to focus on tasks
Hours:
This is a fully onsite role in Sanford, NC
Work schedule is primarily first shift during weekdays, but may include weekends and second and/or third shift hours on occasion to support manufacturing operation activities
Minimal travel required for this position, no more than 5% traveling
Source : Pioneer Data Systems