Associate II - Quality Assurance, Document Control

Catalent Pharma Solutions•Madison, WI

1d•Onsite

About The Position

Associate II, Quality Assurance Systems, Document Control Position Summary: Work Schedule: M-F 8am-5pm 100% on-site Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer’s. Catalent Pharma Solutions in Madison, WI is hiring an Associate II, Quality Assurance Systems, Document Control. The Document Control Quality Assurance Associate is responsible for administering the Document Management System, making documents effective and distribution according to standard operating procedure. This position also corresponds with customers to obtain document approval.

Requirements

Bachelor's Degree, preferably in a STEM discipline with minimum of 1 years related experience, OR Associate’s Degree, preferably in a STEM discipline with minimum of 4 years related experience, OR High School Diploma with a minimum of 6 years related experience.
Must have attention to detail, strong communication skills, ability to work well independently or as part of a team, comfortable using computer systems, and strong customer service skills

Responsibilities

Responsible for execution of the Document Management System
Maintains and enhances effectiveness of the Quality System by maintaining the documentation supporting GMP operations
Manages physical and electronic storage of controlled documents
Accountable for ensuring that executed records are scanned and filed in a timely manner
Collaborate with document owners to ensure the Document Management System operates efficiently and effectively; including executing the document control processes
Assure the integrity of the controlled master documents and controlled executed records are maintained
Management of the document retention room to make certain that GMP documents are readily available for review by auditors and inspectors
Performs filing, scanning, maintenance, and organization of controlled documents
Managing the archival and organization of GMP controlled documents
Assists with document retrieval during customer audits
Maintains data integrity and ensure compliance with company SOP’s, specifications; as well as cGMP, ICH, FDA, EMA regulations or guidelines.
All other duties as assigned

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
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
152 hours of PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
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.
personal initiative.
dynamic pace.
meaningful work.