Quality Assurance Associate Ii, Gmp Systems Compliance And Data Integrity

Catalent Pharma in San Diego, CA is hiring a QA Associate II, 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 must be familiar with applicable GMP regulations and systems and make decisions based those requirements. They should understand the site Quality systems and will begin to expand their knowledge of 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 site-wide operations in a fast-paced, early Phase-focused, dynamic setting.

This is a full-time position: Monday – Friday, 8am-5pm.

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 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, pre-formulation testing, formulation development, GMP 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 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 (daily responsibilities)

• Other duties as assigned.
• Performing manufacturing support activities: Line Clearance, Label Documentation Review, Shipment Documentation/Verification
• Occasional training of other QA personnel.
• Assisting with plans, procedures, and requirements to address data integrity gaps for GMP systems.
• Review and approval of equipment related documentation: Equipment onboarding, Calibration certificates/reports, Validation/qualification reports.
• 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 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.
• Review and approval of site procedures, such as SOPs, FORMs, and validation protocols.

The Candidate (requirements)

• Candidate must have a BS/BA (Bachelor’s) degree in science, business or engineering.
• Candidate must have 2+ years of work experience, preferable in a GMP manufacturing environment or similar.
• 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 co-workers. 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.
• Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude.
• Experience with equipment verification/calibration and supporting documentation highly desired.
• Experience with Blue Mountain, TrackWise, and Microsoft Office preferred.
• Must have familiarity with following ISO/GMP procedures in a regulated environment.

Pay:

• The anticipated salary range for this role in San Diego, CA is $75,000 - $85,000 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 multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
• On-site fitness center and wellness programs
• Several Employee Resource Groups focusing on D&I
• Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment
• Diverse, inclusive culture
• Dynamic, fast-paced work environment
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Environmentally friendly with on-site practices as well as regularly participating in Beach Clean-up activities
• Generous 401K match and Paid Time Off accrual
• Defined career path and annual performance review and feedback process
• Positive working environment focusing on continually improving processes to remain innovative
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• 19 days of PTO + 10 paid holidays
• GymPass program to promote overall physical wellness
• Competitive salary with bonus potential
• Community engagement and green initiatives

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.