Associate II - Quality Assurance, Document Control

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. 

The Role:

• 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
   

The Candidate:

• 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;

Why you should join Catalent:

• 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.

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.