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Quality Assurance Associate, Analytical - San Diego California
Company: Disability Solutions Location: San Diego, California
Posted On: 05/04/2024
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:
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