Senior Scientist I, Quality Control

Catalent • Madison, WI

1d • Onsite

About The Position

Senior Scientist I, Quality Control (Data Review Team)
Position Summary:
Work Schedule: Monday – Friday, core hours 8am-4pm
100% on-site (Madison, WI)
Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.
The Senior Scientist I in the Quality Control (QC) data review team will be responsible for testing products, raw materials and the manufacturing environment to ensure Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility. Other duties will include data review/archiving, database entry/review and contributions to process improvement initiatives.
The Role:
Performs self-review of analytical data for accuracy and consistency with Standard Operating Procedure (SOP). Enter data into Laboratory Information Management System (LIMS) or laboratory reports
Independently executes and properly documents cGMP Quality Control testing. Independently operates basic, moderately complex, and complex cGMP Quality Control equipment
Authors technical documents such as SOPs and reports. Coordinates with Supervisor to prioritize and schedule activities to meet deadlines
Leads continuous process improvement initiatives. Interacts directly with customers. Supports training of specific analytical techniques
Performs general lab housekeeping in adherence to 5S standards. Actively participates in team meetings and/or training sessions
Initiates and leads investigations or deviations in Trackwise. Accurately completes routine and preventive maintenance on basic, moderately complex, and complex equipment
Other duties as assigned
The Candidate:
High School Diploma or equivalent with 11 years of industry experience is required. We will also accept the following experience and education (Biology, Biotech, Chemistry, or related field) combinations: Associate’s Degree and 10 years, Bachelor’s and 6 years, Master’s and 4 years, or a PhD without formal experience
Must have ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP
Must be able to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines
Ability to peer review data to ensure data is well organized with complete documentation. Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions. Must have strong use of Excel, Word, and other office systems. Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy
Must be able to execute/monitor corrective action and independently apply GMPs to everyday work with regard to documentation and instrument use
Ability to apply regulatory authority and guidelines with training
Preferred experience with writing technical documents, maintaining and troubleshooting Quality Control equipment, and familiarity with clean room procedure, aseptic technique, and general lab equipment experience
Physical requirements: Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities
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 PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits
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.

Requirements

• High School Diploma or equivalent with 11 years of industry experience is required. We will also accept the following experience and education (Biology, Biotech, Chemistry, or related field) combinations: Associate’s Degree and 10 years, Bachelor’s and 6 years, Master’s and 4 years, or a PhD without formal experience
• Must have ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP
• Must be able to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines
• Ability to peer review data to ensure data is well organized with complete documentation. Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions. Must have strong use of Excel, Word, and other office systems. Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy
• Must be able to execute/monitor corrective action and independently apply GMPs to everyday work with regard to documentation and instrument use
• Ability to apply regulatory authority and guidelines with training

Nice To Haves

• Preferred experience with writing technical documents, maintaining and troubleshooting Quality Control equipment, and familiarity with clean room procedure, aseptic technique, and general lab equipment experience

Responsibilities

• Performs self-review of analytical data for accuracy and consistency with Standard Operating Procedure (SOP). Enter data into Laboratory Information Management System (LIMS) or laboratory reports
• Independently executes and properly documents cGMP Quality Control testing. Independently operates basic, moderately complex, and complex cGMP Quality Control equipment
• Authors technical documents such as SOPs and reports. Coordinates with Supervisor to prioritize and schedule activities to meet deadlines
• Leads continuous process improvement initiatives. Interacts directly with customers. Supports training of specific analytical techniques
• Performs general lab housekeeping in adherence to 5S standards. Actively participates in team meetings and/or training sessions
• Initiates and leads investigations or deviations in Trackwise. Accurately completes routine and preventive maintenance on basic, moderately complex, and complex equipment
• Other duties as assigned

Benefits

• 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 PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED