Location: Menomonie, WI
Company: Phillips-Medisize
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs involve ensuring that products and services meet certain standards of quality before they reach the consumer. Those in QA roles are responsible for developing and implementing testing processes, inspecting products for defects and non-compliance, and analyzing quality data to drive improvements. A key characteristic of QA positions is the focus on preventing errors rather than just correcting them, which necessitates a proactive approach and attention to detail. Additionally, QA professionals often collaborate closely with production teams to foster a culture of quality throughout an organization.
Quality Assurance (QA) Jobs encompass roles focused on ensuring that products or services meet established standards of quality, reliability, and performance. These positions typically involve identifying defects, designing test procedures, conducting tests, and making improvements. Key characteristics of QA jobs include attention to detail, a strong understanding of quality metrics, the ability to analyze data, and problem-solving skills. Individuals in QA roles work closely with development teams and are critical in maintaining customer satisfaction by preventing errors and enhancing the user experience.
Quality Assurance (QA) Jobs encompass roles focused on ensuring that products or services meet established standards of quality, reliability, and performance. These positions typically involve identifying defects, designing test procedures, conducting tests, and making improvements. Key characteristics of QA jobs include attention to detail, a strong understanding of quality metrics, the ability to analyze data, and problem-solving skills. Individuals in QA roles work closely with development teams and are critical in maintaining customer satisfaction by preventing errors and enhancing the user experience.
is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.
Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. The Quality &
Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.
The Quality & Compliance Senior Specialist I works closely with c GMP groups throughout the facility in order to perform internal audits, and to client audits and regulatory inspections. The Senior Specialist I also works directly with clients to support audits and inspections, as well as to develop process validation documents to support the client project moving from clinical to commercial. The Quality & Compliance team is responsible for ensuring the site remains regulatorily compliant and always inspection
ready. This is a full-time on-site salaried position, Monday - Friday 8:00am to 5:00pm 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: Oversees the internal audit program, including coordinating the audit with relevant department subject matter experts, performing in-depth backssments of systems and procedures; communicating audit findings to key stakeholders; assisting with the development and review of audit responses Oversees the customer audit program, including coordinating audits with the customer and internal stakeholders; hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response and follow up actions Monitors and backsses changes to regulatory guidance and compendial monographs Provides support to ensure that the quality systems are maintained in compliance with regulatory and customer requirements as well as corporate requirements.
Supports and enhances effectiveness of the quality system, including developing and reporting metrics; developing and authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes Drafts, reviews, executes, and approves technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.
g. PPQ, CPV, APR / PQR) All other duties as assigned The Candidate: Requires Doctorate Degree in STEM discipline with minimum of 7 years related experience, OR Master's Degree in STEM discipline with minimum of 10 years related experience, OR Bachelor's Degree in STEM discipline with minimum of 15 years related experience, OR Associate's Degree in STEM discipline with minimum of 17 years related experience.
Knowledge of c GMP, ICH, FDA, EMA regulations or guidelines. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of paid time off annually + 8 paid holidays Competitive salary with yearly 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 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 xyz X@.
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 xyz X@ for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
