Overview
Equipment Validation Specialist Jobs in Portsmouth, NH at Lonza
Quality Assurance Supervisor
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Catalent Pharma Solutions is hiring a Quality Assurance Supervisor. This position reports to the Quality Assurance Manager and supervises the Quality Production Inspectors over a single shift for production related activities that require quality input and oversight. Ensures regulatory compliance with FDA cGMPs, DEA requirements, Clinical Supply Services (CSS) Network Standard Operating Procedures, and Catalent CSS Philadelphia local Standard Operating Procedures. Responsible for leading in production area auditing functions, performing/reviewing product quality complaint investigations and process deviations. Responsible for overseeing special projects, compliance issues and providing possible corrective actions to remedy the issues and prevent future occurrences. The Quality (Operations) Supervisor will be responsible for making quality decisions on behalf of the department when the Quality (Operations) Manager is unavailable. The Quality Assurance department is responsible for ensuring compliance with quality system and product quality requirements defined by international regulations and corporate, network, and local standard operating procedures. The Quality Operations department supports this by providing oversight and guidance on matters affecting the quality system or product quality in daily operations.
This is a full-time role position: Monday-Friday 3:45pm to 12:15am. 2nd Shift. Onsite
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
Supervise daily activities of QA production inspectors, ensuring timely turnaround and appropriate resource assignment to complete /meet the requirements of the daily business activities
Lead/coach/mentor Quality Inspectors to assist the employees in reaching development goals
Understands and partners with Production/Project Management in the management and improvement of Quality-related metrics as follows: Events / Deviations / Complaints / Change Controls, etc
Partners with Production/ Project Management to identify operating efficiencies to continuously improve and promote compliance
Educates Production/ Project Management on regulatory and customer demands which impact upon the achievement of appropriate quality and compliance standards at the facility
Timely completion of product quality investigations, process or procedural deviations, and other quality system reports in TrackWise (as applicable), as well as timely review and approval of those reports completed by Production
Conduct audits of all respective Production areas to assure compliance with cGMPs, corporate and network policies and standards, and local standard operating procedures.
Assist with customer and/or regulatory audits of the facility, as requested
Interacts with customers on behalf of Catalent, as needed, to resolve issues or provide requested information
Promotes a positive attitude and exhibits model behavior
All other duties as assigned;
The Candidate
Required a High School with a minimum of five years of Production Quality Assurance experience
Bachelor’s Degree highly preferred
Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment highly desired
Previous supervisory experience of five years preferred
Good Computer Skills. Knowledge of MS Office and Inventory Management system are a plus
Basic knowledge of Lean Six Sigma methodologies an advantage
Good knowledge of the application of FDA cGMP’s
Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds
Why you should join Catalent:
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
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
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!
WellHub- program to promote overall physical wellness
Perkspot – offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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.
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.
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Title: Equipment Validation Specialist
Company: Lonza
Location: Portsmouth, NH
