Catalent Pharma Solutions in San Diego Clinical Supply Services is hiring a QUALITY ASSURANCE (QA) SPECIALIST.

THIS IS A FULL TIME, SALARIED POSITION: MONDAY-FRIDAY - 8:30AM-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 ANDCOMPLIANCE, AND TO THE SAFETY OF EVERY PATIENT, CONSUMER, AND CATALENT EMPLOYEE.

THE ROLE:

• Responsible for the Quality support functions associated with the packaging of products for clinical and commercial batches;

• Performs batch record review, product release, and disposition;

• Reviews production logbooks for GMP compliance as each operation is completed and revises SOPs as needed;

• Assists in the execution of efficiency improvement projects with guidance;

• Ensures that products are manufactured, packaged, tested and released according to applicable FDA guidelines, regulations GXPs and internal SOPs;

• Participates in QA 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;

• Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label control);

• 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:

• Requires Bachelor’s or a Master’s degree in a scientific discipline AND 1+ years of experience in quality assurance within a regulated environment (pharma, clinical supply, biotech).

• Minimum degree requirements can be replaced by high-school diploma (or equivalent) AND 4+ years of experience in QA in a GMP pharma/clinical supplies environment.

• Six Sigma or ASQ certification preferred.

• Experience with JD Edwards, Trackwise, and strong Excel experience highly preferred.

• Physical requirements: must be able to use computers, identify colors, lift up to 25lbs. and on an average 8-hour day sit, stand, crouch on a regular basis.

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

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Several Employee Resource Groups focusing on D&I

• 19 days of PTO + 10 paid holidays

• Dynamic, fast-paced work environment

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Competitive salary with bonus potential

• Community engagement and green initiatives

• Generous 401K matchand Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement- Let us help you finish your degree or earn a new one!

• On-site fitness center and wellness programs

• Tuition Reimbursement- Let us help you finish your degree or earn a new one!

• GymPass 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.

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.