Quality Assurance Specialist - TechDigital
Summit, NJ
About the Job
50% onsite
PURPOSE AND SCOPE OF POSITION (Position Summary):
The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Vector External Manufacturing. Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports release of vector timeline from the date of manufacture and will support all activities for routine clinical and commercial product release with an emphasis on supporting CMO with a Quality perspective within a regulated cGMP environment.
The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture by ensuring documentation is complete, accurate and that batch records are executed in accordance with approved and effective standard operating procedures and specifications.
QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):
Education: Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree
Experience: 3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Hands-on experience with batch record review and product disposition is preferred.
Strong computer skills with Word and Excel and other electronic manufacturing systems.
Detail oriented team player with effective planning, organization, time management and execution skills.
Proven experience working on teams where combined contribution, collaboration, and results were expected.
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
Ability to work in a high paced team environment.
Strong written and verbal skills.
Licenses/Certifications: N/A
ROLES AND RESPONSIBILITIES:
Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
Provide Quality support and guidance during GMP events and initiation of deviation investigations.
Review deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (cGMPs).
May own department events and minor deviations.
Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
Review and approve change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change
Review, own, edit, and approve controlled documentation in accordance with cGMP standards
Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
May support internal and external audits, including documenting observations and implementation of corresponding CAPAs.
Lead small scope projects as assigned.
Revise Standard operating Procedures as needed.
May train and mentor junior team members.
WORKING CONDITIONS (US Only):
While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
PURPOSE AND SCOPE OF POSITION (Position Summary):
The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Vector External Manufacturing. Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports release of vector timeline from the date of manufacture and will support all activities for routine clinical and commercial product release with an emphasis on supporting CMO with a Quality perspective within a regulated cGMP environment.
The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture by ensuring documentation is complete, accurate and that batch records are executed in accordance with approved and effective standard operating procedures and specifications.
QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):
Education: Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree
Experience: 3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Hands-on experience with batch record review and product disposition is preferred.
Strong computer skills with Word and Excel and other electronic manufacturing systems.
Detail oriented team player with effective planning, organization, time management and execution skills.
Proven experience working on teams where combined contribution, collaboration, and results were expected.
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
Ability to work in a high paced team environment.
Strong written and verbal skills.
Licenses/Certifications: N/A
ROLES AND RESPONSIBILITIES:
Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
Provide Quality support and guidance during GMP events and initiation of deviation investigations.
Review deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (cGMPs).
May own department events and minor deviations.
Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
Review and approve change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change
Review, own, edit, and approve controlled documentation in accordance with cGMP standards
Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
May support internal and external audits, including documenting observations and implementation of corresponding CAPAs.
Lead small scope projects as assigned.
Revise Standard operating Procedures as needed.
May train and mentor junior team members.
WORKING CONDITIONS (US Only):
While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Source : TechDigital
