Veterans Preferred – Lead QA Specialist

Military Veterans are Encouraged to Apply.

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Catalent Pharma Solutions is looking to recruit a Lead QA Specialist to join our growing team in Harmans, MD.

The Lead QA Specialist will Ensure that QA batch record review and lot release deliverables are client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements. The Lead QA Specialist will monitor projects and help resolve issues or escalate appropriately to ensure on time delivery of all client projects with management of effective risk mitigation plans and stakeholder communication. They will also provide QA support for new product introductions at the site.

The Lead QA Specialist role is critical to our patients. The main responsibility is to provide QA oversight and support to client projects making sure the process and document records are in compliance with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!

The Role

• Primary responsibility is to provide QA oversight and support to client projects while working closely with QA Management to ensure QA support for GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product used for human consumption.
• Facilitates resolution to quality issues and interfaces with the client to gain resolution. Ensuring that non-conformances are properly investigated and documented.
• Supports GMP departments in performing, and documenting deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and identifying/implementing effective corrective and preventive actions (CAPAs).
• Evaluate and perform compliance-related data trend analysis and report results. Make recommendations and drive implementation based upon findings.
• Track and evaluate any non-conformances that occur during the manufacture of drug product and evaluate change controls as they impact the project.
• Lead and participate in site quality and process improvement initiatives to ensure compliance and efficiency.

The Candidate

• Minimum of a B.S. in a Life Sciences discipline
• +10 years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
• +6 years’ experience in Quality Assurance/Quality Control function/Manufacturing
• Project Management experience preferred.
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
• Familiarity with compliant 21 CFR Part 11 electronic systems

Catalent’s standard leadership competencies that are used to interview and for Performance & Development

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

Position Benefits

• Potential for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross functional exposure to other areas of within the organization
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• 19 days of paid time off annually + 8 paid holidays

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 customersand 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 www.catalent.com/careers to explore career opportunities.

C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 DisabilityAccommodations@catalent.com . 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.