Quality Assurance Associate I GMP Systems Compliance and Data Integrity

Quality Assurance Associate I GMP Systems Compliance and Data Integrity

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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.

Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development preformulation testing formulation development GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.

Catalent Pharma in San Diego CA is hiring a Quality Assurance Associate I GMP Systems Compliance and Data Integrity. An individual in this role is responsible for a wide variety of activities related to supporting maintaining and ensuring data integrity and compliance for GMP systems. They should develop an understanding of the site Quality systems and will begin to expand their knowledge of applicable GMP regulations and equipment CSV (Computer System Validation) and DI (Data Integrity) requirements. This individual must demonstrate excellent communication critical thinking and organizational skills. This position gives opportunities to develop expertise and expand knowledge of overall sitewide operations in a fastpaced early Phasefocused dynamic setting.

This is a fulltime hourly position: Monday Friday 8am5pm onsite (flexibility in schedule outside of core business hours).

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:

• Review and approval of equipment related documentation: Equipment onboarding Calibration certificates/reports Validation/qualification reports System access reviews
• Performing manufacturing support activities: Production Audits Label Documentation Review Shipment Documentation/Verification
• Review and approval of site procedures such as Standard Operating Procedures (SOPs) FORMs and validation protocols
• Assisting with review and approval of change controls related to site GMP systems and assisting with GMP system periodic reviews
• Assisting with DI compliance assessments of new GMP systems. Enforcing CSV guidelines policies and procedures for production and analytical equipment and IT applications
• Assisting with plans procedures and requirements to address data integrity gaps for GMP systems
• Assisting with identification of data integrity risks and proposing improvement plans. This includes identifying data and systems issues defining requirements and recommending enhancements for system features and related processes
• Other duties as assigned

The Candidate:

• Candidate must have a Bachelors (BS/BA) degree in science business or engineering
• No experience is required with a Bachelors degree but candidates with over 1 year of GMP manufacturing experience are highly preferred
• Candidate must also be highly detailoriented and organized able to work both independently and as a team player with a positive attitude
• Must have familiarity with following ISO/GMP procedures in a regulated environment
• Experience with equipment verification/calibration and supporting documentation highly desired
• Experience with Blue Mountain TrackWise and Microsoft Office preferred
• Physical requirements: Individual may be required to sit stand walk regularly and occasionally lift up to 20 pounds; ability to communicate orally with customers vendors and coworkers. Regular use of telephone and email. Hearing vision and speaking within normal ranges is essential for normal conversations to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals calculator copiers and fax machines. Good reasoning ability is important. Able to understand and utilize management reports memos and other documents to conduct business

Pay:

• The anticipated salary range for this role in San Diego CA is $65000 $70000 annually. The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job type and length of experience within the industry skillset education business needs etc. Catalent is a multistate employer and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• Awesome employee activities: Movie Day Monthly Birthday Celebrations Friday Bagel Breakfast Onsite Fitness Center with machines onsite yoga and HIIT classes Sponsored Sports Teams and several other companysponsored events that encourages positive employee comradery which contributes to effectively building positive employee relationships overall creating a positive work environment.
• Environmentally friendly green initiatives with onsite practices as well as regularly participating in Beach Cleanup activities for community engagement.
• Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Several Employee Resource Groups focusing on Diversity and Inclusion.
• Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical dental and vision benefits effective day one of employment.
• 152 hours of PTO 10 paid holidays.
• Positive and fastpaced working environment focusing on continually improving processes to remain innovative and dynamic.
• Tuition Reimbursement Let us help you finish your degree or earn a new one!
• 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 7000 lifesaving and lifeenhancing 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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.