Catalent Pharma Solutions
Lead Specialist, Client QA
Catalent Pharma Solutions, Harmans, Maryland, United States, 21077
Lead Specialist, Client QALocation: Harmans, MD
Time Type: Full time
Posted on: Posted 5 Days Ago
End Date: December 9, 2024 (22 days left to apply)
Job Requisition ID: 0085266
The
Lead Specialist, Client QA
is responsible for providing QA lead support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. The Client QA Contact serves as the dedicated Client QA Representative and liaisons with the Client and other functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. Responsibilities include tracking and reviewing technology transfer documents, specifications, master batch records, change requests, deviations and failure investigations supporting the release of manufactured material.
The role:
Provides dedicated QA support to client projects and client interactions & meetings.
Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product.
Involved from inception of a client’s project until project closure. Supports Clinical and Commercial QA activities, including initial process development and non-clinical batch production.
Tracks, documents and presents Quality Metrics presentations for Client Projects (on time batch release, right first time, deviations per batch).
Works with clients during initial and subsequent manufacturing campaigns.
Conducts review of master batch records during Technical Transfer for client processes.
Supports GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs).
Performs risk analysis and mitigation, using available tools such as FMEA, when needed.
The candidate:
Masters’ degree in a Scientific, Engineering or Biotech field with 4 – 6 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
Bachelor’s degree in a Scientific, Engineering or Biotech field with 6 - 8 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred.
The anticipated salary range for this position in Maryland is $118,720-$163,240 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
Why you should join Catalent:
Competitive medical benefits and 401K.
152 hours PTO + 8 Paid Holidays.
Dynamic, fast-paced work environment.
Opportunity to work on Continuous Improvement Processes.
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to DisabilityAccommodations@catalent.com.
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Time Type: Full time
Posted on: Posted 5 Days Ago
End Date: December 9, 2024 (22 days left to apply)
Job Requisition ID: 0085266
The
Lead Specialist, Client QA
is responsible for providing QA lead support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. The Client QA Contact serves as the dedicated Client QA Representative and liaisons with the Client and other functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. Responsibilities include tracking and reviewing technology transfer documents, specifications, master batch records, change requests, deviations and failure investigations supporting the release of manufactured material.
The role:
Provides dedicated QA support to client projects and client interactions & meetings.
Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product.
Involved from inception of a client’s project until project closure. Supports Clinical and Commercial QA activities, including initial process development and non-clinical batch production.
Tracks, documents and presents Quality Metrics presentations for Client Projects (on time batch release, right first time, deviations per batch).
Works with clients during initial and subsequent manufacturing campaigns.
Conducts review of master batch records during Technical Transfer for client processes.
Supports GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs).
Performs risk analysis and mitigation, using available tools such as FMEA, when needed.
The candidate:
Masters’ degree in a Scientific, Engineering or Biotech field with 4 – 6 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
Bachelor’s degree in a Scientific, Engineering or Biotech field with 6 - 8 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred.
The anticipated salary range for this position in Maryland is $118,720-$163,240 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
Why you should join Catalent:
Competitive medical benefits and 401K.
152 hours PTO + 8 Paid Holidays.
Dynamic, fast-paced work environment.
Opportunity to work on Continuous Improvement Processes.
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to DisabilityAccommodations@catalent.com.
#J-18808-Ljbffr