Quality Assurance Specialist - Analytical Data Review
POSITION
Summary:
The Quality Assurance Specialist - Analytical Data Review is responsible for providing QA support to the Analytical Development and Quality Control Units, performing analytical method development and review of data generated as part of in-process and release testing of biopharmaceuticals.
The Quality Assurance Specialist role is critical to our patients.
Responsible for data review and data integrity which enhances compliance with patient safety in mind, executing with efficiency always.
Quality, safety, and on-time delivery is a must to be successful in this role! _This position is 100% on site at our Biopark/Baltimore, MD facility 2nd Shift:
Monday through Friday 2pm-10pm.
_ Catalent hires people with a passion to make a difference to the health of millions of people globally.
Your expertise, coupled with Catalents advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.
Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
Interested in learning more about life at Catalent? The Role
?Interface and communicate with the Client, Analytical Development teams, Technology Transfer group and the BMP Manufacturing departments in meeting project timelines, providing deliverables and resolving issues
Perform quality review of Analytical Development documentation including raw data, test methods, protocols and executed method qualification reports; Provide quality oversight of process and analytical method development in an R&D setting for client projects
Support the Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
Support the CAPA Tracking System and track the timely completion and extension of commitments
Conduct review of demonstration batch documentation for accuracy and completeness, documenting deviations and/or failure investigations as appropriate
Generate, revise and review Pre-Clinical Services Standard Operating Procedures (SOPs) and other documentation as needed.
Responsible for material release
Other duties as assigned The Candidate
Minimum of a B.
S.
in a Life Sciences discipline
+3 years experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
+3 years experience in Quality Assurance/Quality Control function reviewing Analytical testing data OR as an Analytical Chemist with some documentation review.
Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
Ability to accept multiple tasks and adjust priority as assigned.
Why you should join Catalent:
Potential for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross functional exposure to other areas of within the organization
Medical, Dental, Vision, and 401K are all offered from day one of employment
19 days of paid time off annually
8 paid holidays 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 exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.
As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyones safety.
The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative.
dynamic pace.
meaningful work.
Visit Catalent Careers (https:
//careers.
catalent.
com/us/en) to explore career opportunities.
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, and confirming your request for an accommodation and include the job number, title and location to email protected .
This option is reserved for individuals who require accommodation due to a disability.
Information received will be processed by a U.
S.
Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives:
Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Thank you.
Important Security Notice to U.
S.
Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media.
If you receive any such request, DO NOT respond it is a fraudulent request.
Please forward such requests to email protected for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https:
//cdn.
catalent.
com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.
pdf).
Recommended Skills Biopharmaceuticals Biotechnology Clinical Works Data Quality Good Manufacturing Practices Ich Guidelines Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
The Quality Assurance Specialist - Analytical Data Review is responsible for providing QA support to the Analytical Development and Quality Control Units, performing analytical method development and review of data generated as part of in-process and release testing of biopharmaceuticals.
The Quality Assurance Specialist role is critical to our patients.
Responsible for data review and data integrity which enhances compliance with patient safety in mind, executing with efficiency always.
Quality, safety, and on-time delivery is a must to be successful in this role! _This position is 100% on site at our Biopark/Baltimore, MD facility 2nd Shift:
Monday through Friday 2pm-10pm.
_ Catalent hires people with a passion to make a difference to the health of millions of people globally.
Your expertise, coupled with Catalents advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.
Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
Interested in learning more about life at Catalent? The Role
?Interface and communicate with the Client, Analytical Development teams, Technology Transfer group and the BMP Manufacturing departments in meeting project timelines, providing deliverables and resolving issues
Perform quality review of Analytical Development documentation including raw data, test methods, protocols and executed method qualification reports; Provide quality oversight of process and analytical method development in an R&D setting for client projects
Support the Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
Support the CAPA Tracking System and track the timely completion and extension of commitments
Conduct review of demonstration batch documentation for accuracy and completeness, documenting deviations and/or failure investigations as appropriate
Generate, revise and review Pre-Clinical Services Standard Operating Procedures (SOPs) and other documentation as needed.
Responsible for material release
Other duties as assigned The Candidate
Minimum of a B.
S.
in a Life Sciences discipline
+3 years experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
+3 years experience in Quality Assurance/Quality Control function reviewing Analytical testing data OR as an Analytical Chemist with some documentation review.
Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
Ability to accept multiple tasks and adjust priority as assigned.
Why you should join Catalent:
Potential for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross functional exposure to other areas of within the organization
Medical, Dental, Vision, and 401K are all offered from day one of employment
19 days of paid time off annually
8 paid holidays 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 exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.
As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyones safety.
The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative.
dynamic pace.
meaningful work.
Visit Catalent Careers (https:
//careers.
catalent.
com/us/en) to explore career opportunities.
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, and confirming your request for an accommodation and include the job number, title and location to email protected .
This option is reserved for individuals who require accommodation due to a disability.
Information received will be processed by a U.
S.
Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives:
Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Thank you.
Important Security Notice to U.
S.
Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media.
If you receive any such request, DO NOT respond it is a fraudulent request.
Please forward such requests to email protected for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https:
//cdn.
catalent.
com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.
pdf).
Recommended Skills Biopharmaceuticals Biotechnology Clinical Works Data Quality Good Manufacturing Practices Ich Guidelines Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
