Catalent Hiring for Quality Engineering Specialist job in Greenville Full Time

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging.

This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.

The Quality Engineering Specialist is responsible for the process of change control and change management and program administration of Management of Change within the quality system as well as identifying risks, clarifying issues, and making recommendations to ensure compliant change management documentation and implementation. The Quality Engineering Specialist provides Quality Assurance oversight of manufacturing, facility, and quality control areas from a validation and systems perspective. The role includes review and approval of key quality system documents and analysis for process improvement and failure reduction activities.

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. 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

• Provide leadership for change control and change management as well as identify risks, clarify issues, and make recommendations to ensure compliant change management documentation and implementation. Identify and recommend opportunities for improved efficiencies in an effort to streamline change control and change management activities and procedures. Serve as Quality Assurance representative for new process and system implementations and cross functional improvement teams.
• Author and review APRs, SOPs, validation documents, and risk assessments for site non-commercial and commercial projects relating to Quality; demonstrated technical writing experience of pharmaceutical documents (e.g. Annual Product Reviews, Risk Assessments, Procedures).
• Lead the Change Management program, including procedures related to ownership of change control and change management of cGMP activities that are compliant and adequate for the business needs; assist with standardization of tools and templates to help those using the process be efficient and effective when executing change related tasks. Lead the Change Management Board meeting, including but not limited to identifying action items, following up and tracking action items to resolution, and providing change control tracking to completion and appropriate retention of pertinent records. Lead the systematic and ongoing review of processes and workflows to improve efficiency and system utilization of the TrackWise Change Management software.
• Identify problems through trend analysis and facilitate independent or team driven problem-solving using root cause analysis.
• Serve as a technical resource for investigations and deviations in all areas of the operation.
• Fulfill expectations, establishes sustainable relationships with clients and team members, maintains effective and meaningful communication channels. Interface with internal non-commercial clients, external commercial clients/partners and all levels of internal clients for commercial processes and projects.
• Provide QA review and approval of validation protocols and reports for manufacturing process, cleaning process, equipment and facility validation activities, for new and existing procedures, change controls, deviations and investigations.
• Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable).
• Other duties as assigned.

The Candidate

• Master’s degree in Physical or Biological Science, Business Administration, Industrial Technologies or Engineering
• Bachelor’s degree with 1 year of professional experience in the pharmaceutical industry
• Associate degree with 2 years of professional experience in the pharmaceutical industry
• Demonstrated technical writing experience (e.g., through related coursework or relevant experience)
• Experience with TrackWise or quality system administration is preferred
• Using a computer and sitting for long periods of time
• Requires the capacity to handle and manipulate objects using hands and arms

Why You Should Join Catalent

• Spearhead exciting and innovative projects
• Fast-paced, dynamic environment
• High visibility to members at all levels of the organization
• 152 hours of PTO + 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 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 .