Specialist I - Quality Assurance

Position Summary

Work Schedule: M-F 8am-5pm
100% on-site

About the role

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 public 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.

Responsibilities

• Accountable for the compliance and effectiveness of the Supplier and Material Quality Assurance programs.
• Manages and maintains the quality Approved Supplier List.
• Schedule and conduct audits of suppliers and vendors in accordance with site policies and procedures.
• Evaluate audit results and follow up on any outstanding issues/actions.
• Leverage audits performed by sister Catalent sites.
• Collaborate with Catalent sister sites and suppliers to draft and maintain Quality Agreements.
• Collaborate with internal Catalent stakeholders to support the Supplier Quality Assurance team in leading corrective action associated with material and supplier quality issues.
• Support the introduction of materials from new suppliers and material qualification program.
• Develop and conduct training to support consistent and accurate execution of the supplier and material quality controls.
• Files and maintains controlled documents.

Requirements

• Doctorate Degree in STEM discipline with minimum of 0 years related experience.
• OR Master's Degree in STEM discipline with minimum of 4 years related experience.
• OR Bachelor's Degree in STEM discipline with minimum of 6 years related experience.
• OR Associates Degree in STEM discipline with minimum of 10 years related experience.
• Ability to use Excel, Word, and other office systems.
• Prior work experience with quality management software such as TrackWise® or ComplianceWire®.
• Ability to independently apply CGMPs to everyday work.
• Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.
• Executes procedures of high complexity with high quality.
• Advanced understanding of pharmaceutical laboratory and/or production operations.

Qualifications

• Doctorate Degree in STEM discipline with minimum of 0 years related experience.
• OR Master's Degree in STEM discipline with minimum of 4 years related experience.
• OR Bachelor's Degree in STEM discipline with minimum of 6 years related experience.
• OR Associates Degree in STEM discipline with minimum of 10 years related experience.
• Ability to use Excel, Word, and other office systems.
• Prior work experience with quality management software such as TrackWise® or ComplianceWire®.
• Ability to independently apply CGMPs to everyday work.
• Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.
• Executes procedures of high complexity with high quality.
• Advanced understanding of pharmaceutical laboratory and/or production operations.

Skills

• Doctorate Degree in STEM discipline with minimum of 0 years related experience.
• OR Master's Degree in STEM discipline with minimum of 4 years related experience.
• OR Bachelor's Degree in STEM discipline with minimum of 6 years related experience.
• OR Associates Degree in STEM discipline with minimum of 10 years related experience.
• Ability to use Excel, Word, and other office systems.
• Prior work experience with quality management software such as TrackWise® or ComplianceWire®.
• Ability to independently apply CGMPs to everyday work.
• Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.
• Executes procedures of high complexity with high quality.
• Advanced understanding of pharmaceutical laboratory and/or production operations.

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!

Pay

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Schedule

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Benefits

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