Quality Assurance Associate I Analytical

Quality Assurance (QA) Associate I Analytical

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 Good Manufacturing Practices (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 Pharma Solutions is hiring a Quality Assurance Associate I Analytical. A QA Associate I must be familiar with applicable GMP for quality standards. 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.

This is a fulltime position: Monday Friday with core hours 8am5pm onsite (offers flexibility with schedule).

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 Standard Operating Procedures (SOPs) Critical Process Parameters (CPPs) protocols test methods and specifications
• Review of analytical release and stability data with minimal supervision
• Review and approval of Out Of Specification (OOS) 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:

• Bachelors degree is required (preferably in Chemistry or Biochemistry)
• Minimum of 1 year of applicable GMP industry experience. Analytical laboratory QC laboratory Manufacturing QA experience may be considered applicable
• Highly preferred to have experience with HPLC HPLC data review and quality systems such as Trackwise and Empower
• Physical Requirements: On an average 8hour day this position requires the ability to walk sit and stand use hands to handle or feel reach with hands and arms at or above shoulder height and below waist height climb or balance stoop kneel crouch or crawl; talk and hear smell and lift up to 15 pounds. Specific vision requirements including reading of written documents visual inspection of materials and use of computer monitor screen frequently

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.