Quality Assurance Manager - Commercial
Catalent Pharma Solutions in Philadelphia, PA is hiring a Commercial Quality Manager.
This position will manage the commercial quality operations for the sites primary and secondary labeling for packaging operations.
They will manage the quality department for the incoming inspection, production inspection, batch record and release functions for commercial product.
Lead the daily quality operations in terms of people, schedule adherence, and Quality Management Systems (QMS).
Lead stakeholders in handling of issues, improvement of metrics, development of models, managing complex problems and development and implementation of preventive or corrective actions.
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 206,878 square-foot facility, located in the Philadelphia area is Catalents global Center of Excellence for Clinical Supply Packaging.
Catalent offers GMP secondary packaging and clinical labeling services throughout our global network.
Packaging can be configured to hold a single product or multiple products as determined by study requirements.
We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes.
For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.
Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies.
Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
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
Collaboration, communication, strategic and critical thinking
Establish and update procedures where appropriate
Perform activities to evaluate, trend and continuously improve systems used
Maintain contact with customers on issues and maintain a good relationship
Use and extract information from the following systems:
Documentum, TrackWise, and ComplianceWire
Monitor and track training for compliance with GMPs and internal procedures
Addressing CAPAs and other customer commitments in a timely manner
Participate in customer audits and ensure 100% on-time responses to any observations
Successfully manage teams to ensure that goals are understood, provide guidance, mentoring and feedback against performance and development objectives
Other duties as assigned.
The Candidate
BS Degree in Chemistry, Biology, Physics, Engineering, or related discipline
Full understanding of cGMP regulations pertaining to commercial packaging
Knowledge of Quality Assurance and regulatory compliance
Ten years of experience working a pharmaceutical industry with at least five years experience in QA/QC areas with progressive responsibilities.
Experience managing people providing leadership and implementing developmental plans for personnel
Good communication skills, both written and verbal
Strong interpersonal skills and is comfortable working in a team environment
Good Computer skills.
Knowledge of MS Office and Inventory Management system are a plus.
Knowledge of the application of FDA cGMPs 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 possible 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 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 Auditing Biology Certified Global Meeting Planner Chemistry Coaching And Mentoring Communication Estimated Salary: $20 to $28 per hour based on qualifications.
This position will manage the commercial quality operations for the sites primary and secondary labeling for packaging operations.
They will manage the quality department for the incoming inspection, production inspection, batch record and release functions for commercial product.
Lead the daily quality operations in terms of people, schedule adherence, and Quality Management Systems (QMS).
Lead stakeholders in handling of issues, improvement of metrics, development of models, managing complex problems and development and implementation of preventive or corrective actions.
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 206,878 square-foot facility, located in the Philadelphia area is Catalents global Center of Excellence for Clinical Supply Packaging.
Catalent offers GMP secondary packaging and clinical labeling services throughout our global network.
Packaging can be configured to hold a single product or multiple products as determined by study requirements.
We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes.
For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.
Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies.
Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
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
Collaboration, communication, strategic and critical thinking
Establish and update procedures where appropriate
Perform activities to evaluate, trend and continuously improve systems used
Maintain contact with customers on issues and maintain a good relationship
Use and extract information from the following systems:
Documentum, TrackWise, and ComplianceWire
Monitor and track training for compliance with GMPs and internal procedures
Addressing CAPAs and other customer commitments in a timely manner
Participate in customer audits and ensure 100% on-time responses to any observations
Successfully manage teams to ensure that goals are understood, provide guidance, mentoring and feedback against performance and development objectives
Other duties as assigned.
The Candidate
BS Degree in Chemistry, Biology, Physics, Engineering, or related discipline
Full understanding of cGMP regulations pertaining to commercial packaging
Knowledge of Quality Assurance and regulatory compliance
Ten years of experience working a pharmaceutical industry with at least five years experience in QA/QC areas with progressive responsibilities.
Experience managing people providing leadership and implementing developmental plans for personnel
Good communication skills, both written and verbal
Strong interpersonal skills and is comfortable working in a team environment
Good Computer skills.
Knowledge of MS Office and Inventory Management system are a plus.
Knowledge of the application of FDA cGMPs 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 possible 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 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 Auditing Biology Certified Global Meeting Planner Chemistry Coaching And Mentoring Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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