QA Investigator- GMP Manufacturing
AstraZeneca AstraZeneca Newark, DE Newark, DE Full-time Full-time 1 day ago 1 day ago 1 day ago At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges.
We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.
We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
In Operations, we have a big ambition - to deliver more medicines to patients, quicker and more affordably.
Backed by the investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.
The AstraZeneca Newark Supply Site in Newark, DE, was established in 1971 and currently employs approximately 260 people.
Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for global supply of sophisticated products.
The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities.
It's important to us that you bring your full self to work every day.
To help maintain your best self, here's a sneak peek into some of the things this site provides for you:
on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.
The Quality Assurance Investigator is responsible for performing investigations and driving each event to a conclusion by working with others.
The QA Investigator also ensures the investigation outcome, root cause analysis, and resulting solutions (CAPAs) are completed in a timely, effective, and compliant manner.
This role will be hired at either an QA Investigator or Senior QA Investigator level depending on the experience and capabilities of the successful candidate.
What you'll do:
Conducts organized investigations with a well-defined scope, strategy, and timeline documenting the status and progress of the investigation and CAPAs.
Authors reports that document the investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
Seeks and demonstrates the skills and technical expertise of internal and external resources to improve the speed and thoroughness of investigations.
Collaborates with an investigation team to determine:
Communication strategy so all collaborators have appropriate information.
Investigation strategy, including a clear and practical problem statement.
Investigation tools.
Investigation action plan and timing.
Root cause.
Solution selection.
CAPA action plan and effectiveness checks.
Utilizes the appropriate and approved investigation tools necessary to drive the team to root cause.
Prioritizes work to aid in timely decisions and completion of investigations.
Escalates issues as appropriate.
Works within and across functions, sites, and regions to ensure connectivity of investigations between functional areas and sites.
Completes other duties as assigned.
Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.
Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.
Report potential issues of non-compliance.
Ensures compliance with AZ Corporate Policies and Directives, site Standard Operating Procedures, regulatory requirements, and industry best practice (cGMPs).
Maintains a safe work environment and performs work in accordance with site Environment, Health, and Safety (SHE) policies, and procedures.
Immediately report potentially unsafe conditions to management.
Excellent written, verbal, and presentation skills needed.
Thorough understanding of the internal core business process including relevant cGMP and regulatory.
Adept at identifying and understanding the critical factors in order to generate appropriate solutions.
Attention to detail and data integrity is essential.
Ability to monitor activities to accomplish stated objectives in an effective manner.
Qualifications:
Required:
1 or more years of experience in quality investigation or similar High School Diploma Ability to quickly assess and assimilate technical data and conduct a thorough investigation; ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
Preferred:
Bachelor's degree in Science, Engineering, or other related technical discipline.
Multiple site or function experience.
Experience in Pharmaceutical Manufacturing and/or other similar regulated industry.
Computer system experience such as TrackWise, SAP, LIMS, and Electronic Batch Record Systems is preferred.
Ability to work in a fast-paced and rapidly changing environment.
Ability to prioritize work activities to meet customer needs and deadlines.
Proficient with Microsoft Office Suite and have a working knowledge, or the ability to learn.
Ability to take accountability with excellent follow up and follow-through; owns issues through the full cycle investigation process.
Why Join Operations? Here we turn molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery.
In our fast-paced, growing environment, embrace an exciting opportunity to build a long-term, varied career.
With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace.
If you have the passion and the drive to accelerate growth and make people's lives better - then this is the place for you.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.
We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
In Operations, we have a big ambition - to deliver more medicines to patients, quicker and more affordably.
Backed by the investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.
The AstraZeneca Newark Supply Site in Newark, DE, was established in 1971 and currently employs approximately 260 people.
Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for global supply of sophisticated products.
The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities.
It's important to us that you bring your full self to work every day.
To help maintain your best self, here's a sneak peek into some of the things this site provides for you:
on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.
The Quality Assurance Investigator is responsible for performing investigations and driving each event to a conclusion by working with others.
The QA Investigator also ensures the investigation outcome, root cause analysis, and resulting solutions (CAPAs) are completed in a timely, effective, and compliant manner.
This role will be hired at either an QA Investigator or Senior QA Investigator level depending on the experience and capabilities of the successful candidate.
What you'll do:
Conducts organized investigations with a well-defined scope, strategy, and timeline documenting the status and progress of the investigation and CAPAs.
Authors reports that document the investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
Seeks and demonstrates the skills and technical expertise of internal and external resources to improve the speed and thoroughness of investigations.
Collaborates with an investigation team to determine:
Communication strategy so all collaborators have appropriate information.
Investigation strategy, including a clear and practical problem statement.
Investigation tools.
Investigation action plan and timing.
Root cause.
Solution selection.
CAPA action plan and effectiveness checks.
Utilizes the appropriate and approved investigation tools necessary to drive the team to root cause.
Prioritizes work to aid in timely decisions and completion of investigations.
Escalates issues as appropriate.
Works within and across functions, sites, and regions to ensure connectivity of investigations between functional areas and sites.
Completes other duties as assigned.
Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.
Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.
Report potential issues of non-compliance.
Ensures compliance with AZ Corporate Policies and Directives, site Standard Operating Procedures, regulatory requirements, and industry best practice (cGMPs).
Maintains a safe work environment and performs work in accordance with site Environment, Health, and Safety (SHE) policies, and procedures.
Immediately report potentially unsafe conditions to management.
Excellent written, verbal, and presentation skills needed.
Thorough understanding of the internal core business process including relevant cGMP and regulatory.
Adept at identifying and understanding the critical factors in order to generate appropriate solutions.
Attention to detail and data integrity is essential.
Ability to monitor activities to accomplish stated objectives in an effective manner.
Qualifications:
Required:
1 or more years of experience in quality investigation or similar High School Diploma Ability to quickly assess and assimilate technical data and conduct a thorough investigation; ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
Preferred:
Bachelor's degree in Science, Engineering, or other related technical discipline.
Multiple site or function experience.
Experience in Pharmaceutical Manufacturing and/or other similar regulated industry.
Computer system experience such as TrackWise, SAP, LIMS, and Electronic Batch Record Systems is preferred.
Ability to work in a fast-paced and rapidly changing environment.
Ability to prioritize work activities to meet customer needs and deadlines.
Proficient with Microsoft Office Suite and have a working knowledge, or the ability to learn.
Ability to take accountability with excellent follow up and follow-through; owns issues through the full cycle investigation process.
Why Join Operations? Here we turn molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery.
In our fast-paced, growing environment, embrace an exciting opportunity to build a long-term, varied career.
With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace.
If you have the passion and the drive to accelerate growth and make people's lives better - then this is the place for you.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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