AGC Inc
Quality Assurance Principal Scientist
AGC Inc, Washington, District of Columbia, us, 20022
Quality Assurance Scientist IApply
Locations: Bothell, Washington, USA
Time Type: Full time
Posted on: Posted 17 Days Ago
Time left to apply: End Date: November 19, 2024 (3 days left to apply)
Job Requisition ID: JR100963
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
SUMMARY:
The QA Product Quality team supports customer products including batch record approval and communication directly with the customer. The team member will also be involved in continuous improvement efforts at AGC Biologics. This team member will provide Quality Assurance organizational support for investigation and closure of quality events including Deviation Investigations, CAPA, and effectiveness verification approval.
KEY RESPONSIBILITIES:
Demonstrates success using compliance knowledge, creativity and regulatory perspectives to solve problems.
Exercises judgment within generally defined practices and policies in interpreting and applying regulations to GMP systems.
Interprets regulations and guidelines critical for advancement of QA systems.
Independently leads compliance activities in CAPA, Change Control, and Deviation quality systems.
Takes an active role in planning and implementation of QA long range goals for further development of key QA initiatives.
Accountable for decisions and results that ensure timelines are met.
May lead projects or represent QA interests in multidisciplinary project teams. Works closely with other team members in a cooperative fashion to ensure project progression.
Responsible for making recommendations in accordance with federal and international regulatory requirements and industry standards.
Quality Representative for investigations during regulatory inspections.
Ability to understand analytical/technical data.
Clear, concise writing skills.
KNOWLEDGE, SKILLS & ABILITIES:
Understanding of Biologics Manufacturing and testing.
Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques.
Knowledge of scientific principles and concepts as they relate to Operations and GMP.
Knowledge of CAPA, change control and deviation programs and requirements.
Great team player who is collaborative and positive.
Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
Strong interpersonal, written/oral communication and problem solving skills.
Experience with regulatory inspections, internal/external audits.
Experience in a Quality environment; Demonstrated knowledge of quality processes and compliance.
Excellent communication and data management skills.
Ability to interact constructively with co-workers.
Ability to negotiate needed actions and manage difficult interactions effectively.
Demonstrated ability to multi-task and work on several projects and problems.
Ability to work under only general direction.
Ability to independently determine and develop approach to solutions.
EDUCATION/EXPERIENCE:
BA/BS with at least 5+ years in direct QA experience, MA/MS with at least 3 years or a PhD in a scientific discipline with at least 2 years related experience; may include post-doctoral experience or equivalent work experience.
Experience with application of compliance principles which drive QA strategy.
Experience in change control facilitation and closure.
Knowledge/Experience in Corrective and Preventative Action (CAPA) facilitation and closure.
Experience with Deviation Investigations.
COMPENSATION:
$83,920 - $115,390
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners. Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. We are an equal opportunity employer.
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Locations: Bothell, Washington, USA
Time Type: Full time
Posted on: Posted 17 Days Ago
Time left to apply: End Date: November 19, 2024 (3 days left to apply)
Job Requisition ID: JR100963
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
SUMMARY:
The QA Product Quality team supports customer products including batch record approval and communication directly with the customer. The team member will also be involved in continuous improvement efforts at AGC Biologics. This team member will provide Quality Assurance organizational support for investigation and closure of quality events including Deviation Investigations, CAPA, and effectiveness verification approval.
KEY RESPONSIBILITIES:
Demonstrates success using compliance knowledge, creativity and regulatory perspectives to solve problems.
Exercises judgment within generally defined practices and policies in interpreting and applying regulations to GMP systems.
Interprets regulations and guidelines critical for advancement of QA systems.
Independently leads compliance activities in CAPA, Change Control, and Deviation quality systems.
Takes an active role in planning and implementation of QA long range goals for further development of key QA initiatives.
Accountable for decisions and results that ensure timelines are met.
May lead projects or represent QA interests in multidisciplinary project teams. Works closely with other team members in a cooperative fashion to ensure project progression.
Responsible for making recommendations in accordance with federal and international regulatory requirements and industry standards.
Quality Representative for investigations during regulatory inspections.
Ability to understand analytical/technical data.
Clear, concise writing skills.
KNOWLEDGE, SKILLS & ABILITIES:
Understanding of Biologics Manufacturing and testing.
Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques.
Knowledge of scientific principles and concepts as they relate to Operations and GMP.
Knowledge of CAPA, change control and deviation programs and requirements.
Great team player who is collaborative and positive.
Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
Strong interpersonal, written/oral communication and problem solving skills.
Experience with regulatory inspections, internal/external audits.
Experience in a Quality environment; Demonstrated knowledge of quality processes and compliance.
Excellent communication and data management skills.
Ability to interact constructively with co-workers.
Ability to negotiate needed actions and manage difficult interactions effectively.
Demonstrated ability to multi-task and work on several projects and problems.
Ability to work under only general direction.
Ability to independently determine and develop approach to solutions.
EDUCATION/EXPERIENCE:
BA/BS with at least 5+ years in direct QA experience, MA/MS with at least 3 years or a PhD in a scientific discipline with at least 2 years related experience; may include post-doctoral experience or equivalent work experience.
Experience with application of compliance principles which drive QA strategy.
Experience in change control facilitation and closure.
Knowledge/Experience in Corrective and Preventative Action (CAPA) facilitation and closure.
Experience with Deviation Investigations.
COMPENSATION:
$83,920 - $115,390
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners. Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. We are an equal opportunity employer.
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