Location: De Forest, WI
Company: Stoughton Trailers
Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory 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.
to automate. Execute software testing across all product lines. Facilitate business user testing activities and sign off of all new product and feature development. Accurately and consistently track defects and work with the engineering team to provide context and support in the resolution of defects and execute re-testing.
Assist with business user training as new features and products are implemented. QUALIFICATIONS: 3+ years experience working as a Quality Analyst Experience in analytics, high level problem solving skills and the ability to maintain a high level of internal customer satisfaction. Support the implementation of best practices in software testing. Experience with various automated testing solutions. Interested candidates can send their updated resumes at xyz X@global- Job Posted by Applicant Pro
