Lead QA Specialist

Lead QA Specialist

Position Summary

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Lead Specialist, QA is responsible for providing QA support to the Analytical Development and Quality Control departments of our Contract Manufacturing Organization, reviewing protocols, reports, quality records, and data packets from executed protocols at Catalent Cell and Gene Therapy.

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

• Maintain and administer quality systems including document management, investigation/deviations, CAPA tracking, risk management, quality metric tracking, training, and other quality systems.
• Interface and communicate with the Client, Analytical Development teams, Method Services group, and the Quality Control departments in meeting project timelines, providing deliverables, and resolving issues.
• Perform quality review of documentation including raw data, test methods, protocols, and executed method qualification/transfer/verification/validation reports.
• Support external client audits and perform periodic walk-through audits of Analytical Development and Quality Control laboratories.
• Provide quality oversight of process and analytical method development in an R&D setting for client projects and quality oversight in compliance with GMPs for Quality Control testing of clinical products.
• Support the Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution. Support the CAPA Tracking System and track the timely completion and extension of commitments.
• Generate, revise, and review Pre-Clinical Services Standard Operating Procedures (SOPs), Standard Test Method (STM) and other documentation as needed.
• Review and approve in-process, release testing, and stability data. Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards. Maintain databases and systems used for tracking various activities.
• Other duties as assigned.

The Candidate

• Masters' degree in a Scientific, Engineering or Biotech field with 4 - 6 years' experience in Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with some documentation review OR
• Bachelor's degree in a Scientific, Engineering or Biotech field with 6 - 8 years' experience in Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with some documentation review.
• Strong communication skills.
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines.
• Familiarity with biological assay and method development (i.e. ELISA, HPLC, ddPCR, Western Blot, qPCR, etc) a plus
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
• Exposure to Lean Operational Excellence highly desirable.
• Ability to work in a lean, action-oriented organization and demonstrate a strong work ethic.
• Must be flexible, adaptable, self-motivated, and able to work well independently and across teams and partners.
• Must be team-oriented (proactively builds healthy working relationships between peers, their department, and other groups).
• Actively pursues learning of required skills, new skills, and new equipment.
• Proficient in MS Office and related PC skills.
• Must have the ability to work an available set shift.

Why You Should Join Catalent

• Competitive medical benefits and 401K
• 19 days of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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 [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.