Lead QA Specialist, Audit Virtual Hiring Event

APPLY: Lead Quality Assurance Specialist- Audit Job in Harmans, Maryland, United States of America, 21077 | Catalent Careers

Catalent Pharma Solutions in Harmans, MD is hiring a Lead Quality Assurance Specialist-Audit. This role is responsible for the execution of the core quality systems and driving compliance at the site including, compiling, trending and reporting key quality metrics for Senior Leadership review, hosting client audits and regulatory inspections, conducting self-inspections, audit observation response coordination and support, commitment generation and tracking and other quality system functions, as needed. Works in a fast-paced environment supporting the overall site for Phase I/II/III and commercial GMP manufacturing of biologic bulk drug substance and sterile finished drug product. Shift work and/or weekend work may be required at times in order to meet project timelines and/or commitments.

This is a full-time role position: Monday – Friday, days.

Catalent hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with 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.

The Role

• Responsible for and administers Audit systems for tracking statuses, follow-up, and liaison with applicable department owners to ensure their complete and timely response and resolution for observations and subsequent commitments
• Perform trending review of observations and commitments, compile report and identify trends or areas requiring additional actions
• Host client audits and regulatory inspections; Manages site audit schedule(s); Tracks Audit Commitment findings to closure
• Create and deliver Quality System/Compliance training as required
• Compile pertinent metrics for Senior Leadership review; Assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Leadership on a periodic basis. Track action items for completion
• Support client projects as necessary
• Maintains databases and systems used for tracking various GMP manufacturing associated support activities; Responsible for the generation and/or revision of GMP documentation such as standard operating procedures; Responsible for regulatory (FDA, EMA) inspections readiness and logistic prep
• Support/execute site self-inspection program; Works closely with manufacturing, Facilities and Quality Control staff to resolve quality issues with regard to the facilities and product manufactured
• Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards
• Other duties as assigned

The Candidate

• B.S. in a Life Sciences discipline and 8 years of relevant or similar experience highly desirable – OR –
• M.S. in a Life Sciences discipline and 6 years of relevant or similar experience
• Experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentation
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• SME/Expert in all Microsoft Applications i.e. EXCEL, PowerPoint, Access, Teams and Sharepoint and Trackwise
• ASQ CQA (American Society of Quality Certified Quality Auditor) highly desirable
• Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820
• Ability to work in fast paced environment supporting the quality assurance/quality control departments of a CMO for Phase I/II/III GMP manufacturing of biologic bulk drug substance and sterile finished drug product. Experience supporting Federal government contracts is a plus

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 19 days of PTO 8 paid holidays
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories

Preferred dress code

Business (business suit, tie)

What is a virtual interview?

Virtual interviews help employers connect with job seekers when they are not in the same physical location. Since hiring is a human process, employers would like to talk with you online (chat, video or phone) to see if you meet the requirements for the job.