CATALENT PHARMA IN SAN DIEGO, CA IS HIRING A QA ASSOCIATE I.

POSITION SUMMARY

A QA Associate I must be familiar with applicable GMP. This individual will be responsible for evaluating the compliance of manufacturing and analytical documents such as test methods, batch records, stability and release data, etc. with supervision. This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills.

In concert with Catalent's Patient First philosophy, this position is key in our efforts toward continuous improvement of our processes & information which will allow quality drug products to reach patients safely and efficiently.

Catalent Pharm 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 manufacturing and stability storage and testing. 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

• Review and approval of controlled documents such as SOPs, CPPs (Corporate Policies and Procedures), protocols, test methods, and specifications.

• Review of analytical release and stability data, with minimal supervision.

• Review and approval of OOS (Out of Spec) and Variance documentation under supervision.

• Supporting role in manufacturing activities including but not limited to line clearance, label quarantine/release, cleaning verification review, and raw material release data review.

• Supporting role in internal audits, external audits and client audits.

• Other duties as assigned.

THE CANDIDATE

• Minimum of 1 years of applicable GMP industry experience. Analytical laboratory, QC laboratory, Manufacturing, QA experience may be considered applicable.

• Bachelor of Science degree, preferably in Chemistry or Biochemistry

• Strong communication (written and verbal)

• Strong attention to detail in reviewing data, critical thinking to draw conclusions from data, and catching errors and mistakes.

• Use of MS Office required; use of Empower desired.

• Physical Requirements: This employee is regularly required to lift approximately 25lbs and walk/stand/sit/reach/crouch.

WHY YOU SHOULD JOIN CATALENT:

• 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.

• Environmentally friendly with on-site practices as well as regularly participating in Beach Clean-up activities.

• High visibility to Senior Leadership daily.

• Medical, Dental, Vision and 401K are all offered from day one of employment.

• 19 days of paid time off annually and seven paid holidays.

• Tuition Reimbursement.

• Community Volunteer events.

CATALENT'S STANDARD LEADERSHIP COMPETENCIES THAT ARE USED TO INTERVIEW AND FOR PERFORMANCE & DEVELOPMENT:

• Leads with Integrity and Respect

• Delivers Results

• Demonstrates Business Acumen

• Fosters Collaboration and Teamwork

• Champions Change

• Engages and Inspires

• Coaches and Develops

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 DisabilityAccommodations@catalent.com . 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 spam@catalent.com for us to investigate with local authorities.

Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.