Quality Assurance Associate, Analytical

Company: Disability Solutions
Location: San Diego
Posted on: April 19, 2024

Job Description:

Quality Assurance Associate, Analytical Position Summary:Catalent Pharma Solutions in San Diego, CA is hiring a Quality Assurance (QA) Associate, Analytical. The QA Associate must be familiar with applicable GMP. 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, 8am-5pm on-site.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 and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role:

• Review of analytical release and stability data, involving review of Potency tests of investigational new tablets and capsules using High Performance Liquid Chromatography (HPLC) or Ultra Performance Liquid Chromatography, Water Content using Karl Fischer Titration and Karl Fischer Oven, physical characterization of crystalline and partially crystalline solids using tests like Powder X-Ray Diffraction (PXRD), Thermogravimetric analyzer (TGA) and Differential Scanning Calorimeter (DSC). Review Hardness testing and Friability of tablets, Content Uniformity and Blend Uniformity using HPLC, Dissolution of tablets and capsules using UPLC or UV-Vis Spectroscopy, testing for Residual Solvents using Gas Chromatography (GC) and Microbial Enumeration Testing (MET) of samples using Empower 3 for HPLC and UPLC, Tiamo for the Karl Fischer Oven, Miniflex Guidance for PXRD, and the Trios Guardian Software for TGA and DSC.
• Review and approve controlled documents including protocols, test methods, master batch records, and specifications for analytical testing.
• Lead role in onboarding new compounds to the site involving review of toxicology data and performing a nitrosamine assessment to ensure the risks of a new compound are considered against site capabilities.
• Perform internal and external audits. Lead or support client audits along with the Director and Associate Director of Quality Assurance.
• Manage a direct report and train the direct report on analytical data review of stability and release data.
• Perform Line Clearance activities to ensure the correct equipment and materials have been staged in the manufacturing suite before the production begins.
• Perform the release, quarantine and rejection of raw materials used in the production of samples and approve the respective specification of raw materials.
• Review calibration, validation and preventative maintenance certificates of laboratory and manufacturing equipment.
• Point person for safety complaints and improvements in the Quality Assurance Department using the Intelex software for logging complaints.
• Other duties as assigned.The Candidate:
  • Requires a Bachelor's degree in Biotechnology (or related field) plus a minimum of 2 years of experience in a related occupation.
  • Related occupation experience is: Reviewing of analytical release and stability data, involving review of Potency tests of investigational new tablets and capsules using High Performance Liquid Chromatography (HPLC) or Ultra Performance Liquid Chromatography, Water Content using Karl Fischer Titration and Karl Fischer Oven, physical characterization of crystalline and partially crystalline solids using tests like Powder X-Ray Diffraction (PXRD), Thermogravimetric analyzer (TGA) and Differential Scanning Calorimeter (DSC). Review Hardness testing and Friability of tablets, Content Uniformity and Blend Uniformity using HPLC, Dissolution of tablets and capsules using UPLC or UV-Vis Spectroscopy, testing for Residual Solvents using Gas Chromatography (GC) and Microbial Enumeration Testing (MET) of samples using Empower 3 for HPLC and UPLC, Tiamo for the Karl Fischer Oven, Miniflex Guidance for PXRD, and the Trios Guardian Software for TGA and DSC.
  • Must have experience with reviewing and approving method validation reports for analytical testing, performing internal and external audits, and training new hires on analytical review of stability data.
  • Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
  • 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 25 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 $128,128 - $130,000 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!
      • 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 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, El Cajon , Quality Assurance Associate, Analytical, Other , San Diego, California