QA Associate, Clinical Supplies

Quality Assurance Associate, Clinical Supplies

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, 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 Solutions in San Diego, CA is hiring a Quality Assurance (QA) Associate for our Clinical Supplies team. Under general supervision, the QA Associate performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. This individual follows established protocols and work plans, and may be assisted by QA Specialists and Sr. Specialists. This role is essential to comply with divisional and site Environmental Health and Safety (EHS) requirements.

This is a full-time hourly position on-site: Monday-Friday on 1st shift (day shift).

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:

• Responsible for inspection of incoming materials for GMP production. Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label inspection, line clearance, etc.)
• Reviews production batch records, logbooks and other associated documents. Performs Quality verification of just-in-time labeling activities
• Performs document issuance, scanning, filing and archival activities. Revises SOPs, Work Instructions and Forms pertaining to their area of focus, as needed. Assists in the execution of efficiency improvement projects with guidance
• Ensures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs
• Participates in Quality programs, procedures and controls to ensure that products conform to established standards and agency guidelines. Ensures gathering of data, investigations and deviations are timely and compliant
• Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
• Respond and interact with internal and external clients in a professional and timely manner
• Other duties as assigned.

The Candidate:

• Associate’s Degree or equivalent knowledge and experience is required. Lean Six Sigma or ASQ Certification is preferred
• Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form. Must be able to use existing procedures to solve routine and non-routine problems
• Must be able to utilize all elements of the quality system to identify, classify and control the status of incoming materials
• Recognizes unmet needs within department and business
• Mathematical and scientific reasoning ability. Ability to identify aberrant data and potential quality/compliance concerns escalating to management
• 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 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently

Pay:

• The anticipated starting salary range for this role in San Diego, CA is $56,000 to $61,000 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 building positive employee relationships, overall creating a positive work environment.
• Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up 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 fast-paced 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 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. 

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.

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