Quality Assurance Associate

Company: Sant-- Laboratories
Location: Austin
Posted on: August 6, 2022

Job Description:

Job Title: -Quality Assurance Associate - - - - - - - - - - - - - - - - - - - - - - - - - - - - -FLSA: -Full-time, ExemptSupervised by: -Quality DirectorPosition Supervises Others: -NoPosition SummaryThe Quality Assurance Associate is primarily responsible for supporting and improving the quality management system at Sant-- Labs. -This position reports to the Quality Director, and is accountable to the CSO. This position is expected to contribute to the continuous improvement of policies, processes, procedures, and controls to ensure that all Sant-- products conform to a high standard of quality.ResponsibilitiesCollaborate with manufacturing, lab, supply chain, and R&D associates to achieve the following:

• Support both the GMP and ISO 17025 quality systems to achieve and maintain accreditation
• Support the equipment calibration, qualification, preventative maintenance, installation, and repair program
• Assist in the creation and issuance of batch records, master manufacturing mecords, product release specifications, and material release specifications
• Assist in the creation and issuance of Certificates of Analysis for ISO and GMP operations
• Maintain the controlled document system
• Maintain the material specifications & inspection logs
• Draft, revise, and review standard operating procedures (SOPs) for QMS applications
• Update the control charts (Levey-Jennings Chart) for each analytical test method to determine measurement uncertainty and visualize trends in quality control over time
• Maintain the master document lists
• Maintain training records and re-qualifications
• Maintain supplier re-qualifications
• Obtain and organize all certificates of analysis and certificates for incoming materials
• Submit samples of incoming material for testing to verify that it meets the raw material specifications
• Perform cleaning verification prior to each manufacturing operation
• Review & scan documents to the online QMS system
• Maintain a record of current inventory and amount of material used in each manufacturing batch
• Maintain the proficiency test schedule for all analytical methods
• Perform traceability exercises in accordance with the standard operating procedure
• Perform internal audits under the lead of the quality management
• Maintain management review meeting records
• Work with Executive Management to review investigations including compliant and properly documented material and product disposition
• Perform and document corrective and preventive actions for OOS products
• Support of Quality Technical Record systems
• Maintain a record of activities and follows applicable SOPs and good documentation practices
• Comply with applicable regulatory and Quality System requirements
• Execute detailed notetaking for the record and for the purpose of reporting errors and issues
• Aid in the development of new methods and their documentation.
• Adhere to local, state, and federal regulations and requirements for ISO 17025 and cGMP.
• Update and regulate safety protocol documentation to certify that it is up to date. -Critical Skills and Knowledge

• Minimum 4-year degree in a relevant scientific track and/or equivalent training
• Industry experience includes: working in a regulated environment (e.g. FDA), drug formulations lab, biotech or food manufacturing, performing cell culture studies, and working with nanoparticles a plus
• Ability to work independently as well as in a team
• Self-starter, resourceful, flexible, responsive, detail oriented and possess a good work ethic
• Must possess excellent attention to detail, written and verbal communication skills
• Ability to draft and maintain accurate and detailed records of work performed
• Must be able to stand for extended periods of time
• Must be able to lift 25 lbs or more
• Adequate vision (corrected or uncorrected) to read fine instruments such as caliper, instrument displays, etc. and perform visual inspections for defects
• Working knowledge of Microsoft Productivity Software (Word, Excel, Power Point, etc)About Sant-- Laboratories:With 6 patent families and 28 granted and pending patent applications, Sante Laboratories lipid encapsulation technologies are a unique, scalable solution to solubility and stability. We've identified specific ratios of excipients to render nutraceutical and pharmaceutical active ingredients room temperature stable within lipid nanoparticle structures in an aqueous environment, plus we've created the processing conditions to scale it successfully fit for players with omni channel distribution.We work with large ingredient suppliers and multinational brands to fortify finished products with essential vitamins and functional ingredients capable of transparent labels and accurate claims. Our technology is leveraged in end-use applications today's consumers demand like beverages, snacks, on-the-go solutions, and more to capture new market share, innovate product verticals, solubilize unmanageable doses, power underutilized ingredients, and feature ingredients that historically weren't an option.Far superior to the one-size-fits-all technologies currently available in market that can't be scaled for mass distribution, Sante Laboratories has taken the traditional Pharma Model as a CDMO. Delivering as a strategic partner with diverse capabilities, clients engage Sante Laboratories for R&D formulation development, supported by their in-house internationally accredited analytical lab for speed to market, and manufacture bulk liquid that can be used as an ingredient in finished products, as a ready-to-use good, or dehydrated into a powder.Clients are using Sante Laboratories technologies as an end-to-end solution provider for reasons including but not limited to: tunability of particle size and type fit to active ingredients and the end use application, clean labels without the use of surfactants, solubility both in finished goods but also within the body, batch-to-batch consistency, water based finished formula that does not change the characteristics including taste and texture of the finished good it will be used in.At our facility in Austin, Texas clients engage us for R&D to formulate according to target product profiles outlining physical and chemical characteristics. Complete with an internationally accredited ISO analytical in house laboratory we tech transfer from bench top to commercial scale manufacturing. We then manufacture their formulation as a bulk liquid that can be used as an ingredient in finished products or as a ready-to-use good. The bulk liquid can also be spray dried or lyophilized into a powder that when hydrated in various liquids, like gastrointestinal fluids or aqueous beverages, rapidly reconstitutes back into stable, encapsulated lipid particles.Working Conditions
  • This position may require heavy lifting, exposure to potentially hazardous chemicals and active pharmaceutical ingredients.
  • May require periodic evening, weekend and holiday work, as necessary, to meet company deadlinesThis job description in no way states or implies that these are the only activities to be performed by the employee occupying this position. -Employees will be required to follow any other job-related instructions and to perform any other job-related responsibilities requested by their supervisor.

Keywords: Sant-- Laboratories, Austin , Quality Assurance Associate, Professions , Austin, Texas