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 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 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, 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 full-time position: Monday – Friday, with core hours 8am-5pm on-site (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:

• Bachelor’s 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 8-hour 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 $65,000 - $70,000 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:

• 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 buil