Daley And Associates, LLC
Senior Associate at Daley & Associates, LLC.
Senior QA Specialist
Location: Boston, MA Contract: 1-Year (Potential for Extension) Shift: Second Shift — Wednesday–Saturday or Sunday–Wednesday, 12:30 PM–11:00 PM Pay Rate: $55–$65 per hour
Our client is a leading pharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of innovative therapeutic treatments. They are seeking a Senior Quality Assurance (QA) Specialist to provide quality oversight and ensure compliance with cGMP standards in support of both clinical and commercial drug product operations.
Key Responsibilities
Provide QA oversight and support for Cell and Gene Therapy operations, including manufacturing, analytical laboratories, materials management, and facilities/engineering.
Lead QA initiatives to establish new programs for drug product facilities, including start‑up of assembly, packaging, and labeling operations.
Manage batch disposition activities, including review of batch records, deviations, in‑process data, environmental monitoring, QC release testing, and other quality system records to determine product release eligibility.
Review and approve Certificates of Analysis (COAs) and oversee product release processes.
Provide on‑floor QA support to ensure product quality and compliance during manufacturing, and guide resolution of product quality issues or investigations.
Review and approve manufacturing and GMP documentation, including SOPs, batch records, and change controls.
Develop and deliver training programs on GMP and quality systems.
Draft, review, and revise Quality Agreements with CMOs and suppliers.
Support and lead investigations (OOS, OOT, deviations) and ensure appropriate CAPAs are identified and implemented.
Offer technical QA guidance on fill‑finish and aseptic processing operations.
Participate in and support technical transfers, engineering projects, and compliance walkthroughs, ensuring timely closure of any identified observations.
Identify and communicate risks or process gaps related to GMP systems and quality process optimization.
Contribute to inspection readiness activities and continuous improvement initiatives within QA operations.
Qualifications
Master’s degree with 2–3 years of relevant experience, or
Bachelor’s degree in a scientific or allied health field with 3–5 years of relevant experience, or
Equivalent relevant experience in QA or GMP operations.
Demonstrated QA oversight in GMP manufacturing and batch release.
Hands‑on experience with ATMP (Advanced Therapy Medicinal Products) development and manufacturing.
Strong working knowledge of cell and gene therapy cGMPs and associated CMC regulatory requirements.
Experience with aseptic processing, deviation management, QC data review, and CAPA investigations.
Familiarity with Oracle, TrackWise, and other quality management systems.
Proven success in handling product complaints and recall investigations.
If you are interested in this opportunity, please email your resume to Alanna at aross@daleyaa.com. IND123
#J-18808-Ljbffr
Location: Boston, MA Contract: 1-Year (Potential for Extension) Shift: Second Shift — Wednesday–Saturday or Sunday–Wednesday, 12:30 PM–11:00 PM Pay Rate: $55–$65 per hour
Our client is a leading pharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of innovative therapeutic treatments. They are seeking a Senior Quality Assurance (QA) Specialist to provide quality oversight and ensure compliance with cGMP standards in support of both clinical and commercial drug product operations.
Key Responsibilities
Provide QA oversight and support for Cell and Gene Therapy operations, including manufacturing, analytical laboratories, materials management, and facilities/engineering.
Lead QA initiatives to establish new programs for drug product facilities, including start‑up of assembly, packaging, and labeling operations.
Manage batch disposition activities, including review of batch records, deviations, in‑process data, environmental monitoring, QC release testing, and other quality system records to determine product release eligibility.
Review and approve Certificates of Analysis (COAs) and oversee product release processes.
Provide on‑floor QA support to ensure product quality and compliance during manufacturing, and guide resolution of product quality issues or investigations.
Review and approve manufacturing and GMP documentation, including SOPs, batch records, and change controls.
Develop and deliver training programs on GMP and quality systems.
Draft, review, and revise Quality Agreements with CMOs and suppliers.
Support and lead investigations (OOS, OOT, deviations) and ensure appropriate CAPAs are identified and implemented.
Offer technical QA guidance on fill‑finish and aseptic processing operations.
Participate in and support technical transfers, engineering projects, and compliance walkthroughs, ensuring timely closure of any identified observations.
Identify and communicate risks or process gaps related to GMP systems and quality process optimization.
Contribute to inspection readiness activities and continuous improvement initiatives within QA operations.
Qualifications
Master’s degree with 2–3 years of relevant experience, or
Bachelor’s degree in a scientific or allied health field with 3–5 years of relevant experience, or
Equivalent relevant experience in QA or GMP operations.
Demonstrated QA oversight in GMP manufacturing and batch release.
Hands‑on experience with ATMP (Advanced Therapy Medicinal Products) development and manufacturing.
Strong working knowledge of cell and gene therapy cGMPs and associated CMC regulatory requirements.
Experience with aseptic processing, deviation management, QC data review, and CAPA investigations.
Familiarity with Oracle, TrackWise, and other quality management systems.
Proven success in handling product complaints and recall investigations.
If you are interested in this opportunity, please email your resume to Alanna at aross@daleyaa.com. IND123
#J-18808-Ljbffr