Senior Quality Assurance Specialist (Clinical Supplies)

Position Summary:

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 (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 in San Diego, CA is hiring a Senior Quality Assurance (QA) Specialist in our Clinical Supply facility. The Senior Specialist provides regulatory expertise to the investigation and deviation management process. Some evaluation, originality or ingenuity is required. This individual follows established protocols and work plans and may be assisted by other members of the QA department. The QA specialist will also comply with divisional and site Environmental Health and Safety requirements.

This is a full-time salaried position: Monday – Friday, 8am-5pm. PLEASE NOTE: This position may require a 1 week training period in Kansas City, MO.

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 (Good Manufacturing Practices) production, and assist with packaging floor activities for primary and secondary packaging (equipment/room approval, facility compliance, auditing, label inspection, line clearance, etc.)

• Performs production batch record review/approval, performs COCs (Certificate of Compliance), review production logbooks and other associated documents. Revises SOPs, Work Instructions and Forms pertaining to their area of focus

• Performs Quality verification of just-in-time labeling activities, document issuance, scanning, filing and archival activities. Reviews and tracks investigations/deviations and corrective actions for the site

• Ensures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs (Standard Operating Procedures).

• 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. Assists in the execution of efficiency improvement projects with guidance. Train, coach, and mentor others on technical knowledge, personal development, and business issues

• Other duties as assigned

The Candidate:

• Bachelor’s or Master’s degree in a scientific discipline is required

• Must have a minimum of five years of applicable pharmaceutical GMP QA knowledge (i.e. investigations/deviations, QC lab, Manufacturing, batch record review, product release, packaging floor QA, auditing, line clearance, etc.)

• Six Sigma or ASQ certification preferred. Candidates with experience in a GMP QA setting will be favorably considered

• Must have the ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form

• Must be able to proactively address work issues at the individual and team level. Use mathematical and scientific reasoning ability to identify aberrant data and potential quality/compliance concerns escalating to management

• Must have the ability to collaborate with peers and demonstrate leadership capabilities in a matrix environment. Excellent written and verbal communications skills with internal and external customers, peers and managers required

• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and fax machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business

Pay:

• The anticipated salary range for this role in San Diego, CA is $87,000 - $95,000 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 (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .