Quality Control Data Reviewer and Stability Coordinator
Position
Summary:
Catalent Pharma Solutions is Chelsea, MA is hiring a Quality Control Data Reviewer and Stability Coordinator who is responsible for review of data generated in the QC laboratory for both release and stability samples.
Will oversee the commercial stability programs, including coordinating set down and pulls according to approved plans and protocols.
The QC Data Reviewer and Stability Coordinator will generate reports and CoAs to document results.
This is a full-time role position:
Monday - Friday, days.
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.
Your talents, ideas, and passion are essential to our mission:
to help people live better, healthier lives.
This 90,000 square-foot Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging.
The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging.
On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role Review of GMP data generated by QC group, including release and stability data.
Generate Certificate of Analysis.
Generate interim and final stability reports.
Oversee the commercial stability program.
Coordinate stability pulls for samples stored both on-site and off-site.
Coordinate stability set down for samples stored both on-site and off-site.
Assist with data interpretation and use conclusions to propose follow up experiments, as necessary, for Out of Specification investigations and analytical deviations.
All other duties as assigned; The Candidate Bachelor's Degree in Physical or Chemical Sciences (life sciences) required.
Minimum of 2-5 years of experience in a cGMP regulated environment required.
Experience in MDI/DPI analytical test methods (i.
e.
Andersen Cascade Impactor and Emitted Dose techniques) preferred.
Understand and apply ICH and FDA guidance where needed.
Understand cGMPs, Catalent SOPs and Catalent Quality systems applicable to work performed.
Stay current with analytical technology industry standards and equipment.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds; Why you should join Catalent:
Defined career path and annual performance review and feedback process Diverse, inclusive culture 19 days of PTO
8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Employee Stock Purchase Program Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Competitive salary with bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or earn a new one! GymPass program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900
merchants in a wide array of categories 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 everyone's 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 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.
Recommended Skills Certified Global Meeting Planner Experimentation Pharmaceuticals Quality Management Research Test Method Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
Catalent Pharma Solutions is Chelsea, MA is hiring a Quality Control Data Reviewer and Stability Coordinator who is responsible for review of data generated in the QC laboratory for both release and stability samples.
Will oversee the commercial stability programs, including coordinating set down and pulls according to approved plans and protocols.
The QC Data Reviewer and Stability Coordinator will generate reports and CoAs to document results.
This is a full-time role position:
Monday - Friday, days.
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.
Your talents, ideas, and passion are essential to our mission:
to help people live better, healthier lives.
This 90,000 square-foot Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging.
The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging.
On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role Review of GMP data generated by QC group, including release and stability data.
Generate Certificate of Analysis.
Generate interim and final stability reports.
Oversee the commercial stability program.
Coordinate stability pulls for samples stored both on-site and off-site.
Coordinate stability set down for samples stored both on-site and off-site.
Assist with data interpretation and use conclusions to propose follow up experiments, as necessary, for Out of Specification investigations and analytical deviations.
All other duties as assigned; The Candidate Bachelor's Degree in Physical or Chemical Sciences (life sciences) required.
Minimum of 2-5 years of experience in a cGMP regulated environment required.
Experience in MDI/DPI analytical test methods (i.
e.
Andersen Cascade Impactor and Emitted Dose techniques) preferred.
Understand and apply ICH and FDA guidance where needed.
Understand cGMPs, Catalent SOPs and Catalent Quality systems applicable to work performed.
Stay current with analytical technology industry standards and equipment.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds; Why you should join Catalent:
Defined career path and annual performance review and feedback process Diverse, inclusive culture 19 days of PTO
8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Employee Stock Purchase Program Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Competitive salary with bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or earn a new one! GymPass program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900
merchants in a wide array of categories 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 everyone's 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 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.
Recommended Skills Certified Global Meeting Planner Experimentation Pharmaceuticals Quality Management Research Test Method Estimated Salary: $20 to $28 per hour based on qualifications.
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