Daley And Associates, LLC
Overview
Senior QA Specialist for a 1-year contract (potential to extend) with a leading pharmaceutical company focused on discovering, developing, manufacturing, and commercializing therapeutic treatments. This role coordinates GMP activities in support of clinical and commercial drug product disposition. This is a second shift position, either Wed-Sat 12:30 - 11pm, or Sun-Wed 12:30 - 11pm. Responsibilities
Providing quality oversight and support to Cell and Gene Therapy operations in the following key areas/activities: support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
Lead QA efforts to establish new programs to support drug product facility including start-up of assembly, packaging and label operations.
Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
Responsible for review and approval of COAs, and product release.
Provide production floor support and guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
Review and approval of manufacturing documents.
Develop and deliver technical training programs.
Support drafting and revising Quality Agreements between CMOs/Suppliers and the company, as needed.
Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.
Provide experienced technical advice for fill finish related program decisions.
Provide project support involving technical transfers, engineering projects and similar activities.
Participate in compliance walkthroughs and help drive the closure of any observations.
Identify risks and communicate gaps for GMP process/systems.
Identify risks and communicate gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
Participate in continuous improvements of department processes.
Participate in inspection readiness and support activities.
Participate in process improvement initiatives (as necessary).
Qualifications
Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.
Experience providing QA support and oversight of GMP manufacturing operation including batch release.
Experience with ATMP drug product development and manufacturing with proficiency.
Knowledge of the following in a pharmaceutical setting: Cell and gene therapy cGMPs and associated CMC regulatory considerations
Aseptic processing
Experience successfully leading event investigations, Root Cause Analysis and CAPA.
Experience with network-based applications such as Oracle, TrackWise.
Experience on product complaints investigations and recalls.
Ideal candidate will have strong experience in deviation, QC data review, quality events, QA operations, documentation and batch review.
Strong leadership skills with the ability to thrive in a high throughput environment.
Expert knowledge of GMP requirements governing oral drug products manufacturing practices.
Proven experience supporting GMP manufacturing either via experience in manufacturing and/or experience providing QA operational support of GMP Manufacturing.
Salary
$55 - 65/hr
How to apply
If you are interested in this position, please send your resume to apowell@daleyaa.com
#J-18808-Ljbffr
Senior QA Specialist for a 1-year contract (potential to extend) with a leading pharmaceutical company focused on discovering, developing, manufacturing, and commercializing therapeutic treatments. This role coordinates GMP activities in support of clinical and commercial drug product disposition. This is a second shift position, either Wed-Sat 12:30 - 11pm, or Sun-Wed 12:30 - 11pm. Responsibilities
Providing quality oversight and support to Cell and Gene Therapy operations in the following key areas/activities: support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
Lead QA efforts to establish new programs to support drug product facility including start-up of assembly, packaging and label operations.
Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
Responsible for review and approval of COAs, and product release.
Provide production floor support and guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
Review and approval of manufacturing documents.
Develop and deliver technical training programs.
Support drafting and revising Quality Agreements between CMOs/Suppliers and the company, as needed.
Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.
Provide experienced technical advice for fill finish related program decisions.
Provide project support involving technical transfers, engineering projects and similar activities.
Participate in compliance walkthroughs and help drive the closure of any observations.
Identify risks and communicate gaps for GMP process/systems.
Identify risks and communicate gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
Participate in continuous improvements of department processes.
Participate in inspection readiness and support activities.
Participate in process improvement initiatives (as necessary).
Qualifications
Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.
Experience providing QA support and oversight of GMP manufacturing operation including batch release.
Experience with ATMP drug product development and manufacturing with proficiency.
Knowledge of the following in a pharmaceutical setting: Cell and gene therapy cGMPs and associated CMC regulatory considerations
Aseptic processing
Experience successfully leading event investigations, Root Cause Analysis and CAPA.
Experience with network-based applications such as Oracle, TrackWise.
Experience on product complaints investigations and recalls.
Ideal candidate will have strong experience in deviation, QC data review, quality events, QA operations, documentation and batch review.
Strong leadership skills with the ability to thrive in a high throughput environment.
Expert knowledge of GMP requirements governing oral drug products manufacturing practices.
Proven experience supporting GMP manufacturing either via experience in manufacturing and/or experience providing QA operational support of GMP Manufacturing.
Salary
$55 - 65/hr
How to apply
If you are interested in this position, please send your resume to apowell@daleyaa.com
#J-18808-Ljbffr