Quality Control Lead

3 weeks ago


Aliso Viejo, United States Leo Corps, Inc. Full time
Job DescriptionJob Description

General Responsibilities include:

  • Assist managers in registering bioprocesses info. into database.
  • Follow Chief Scientific officer and quality assurance executives/management guidelines and expectations and tasks assigned.
  •  CAPA and Deviation investigation
  • Audits
  • oversee all aspects lab quality system and implement procedures 
  • Assist with documentation, verifying and keeping records on incoming and outgoing shipments.
  • Prepare all Microbiology and Endotoxin Samples for shipping to outside vendor (lab), including but not limited to final visual inspection, documentation, labeling or stamping and packaging.
  • Cryopreservation and thawing.
  • Read, write, and follow standard operating procedure, technical Lab forms and validations.
  • Maintain accurate laboratory and Batch records within the system (hard copies and soft copies).
  • Perform Cell Isolation Processes for all available technologies in controlled environmental room, tissue processing, Process disposables supplies and reagent inventory.
  • Perform product testing per ISO/IEC 17025 methodology. Follow and maintain the product testing requirements and guidelines.
  • Follow and maintain defined responsibilities of Aseptic operations.
  • Follow and maintain company’s strict confidentiality requirements.
  • Process and discard any failed bioprocess batches per SOP.
  • Maintain correct records for all bioprocesses and biobanking.
  • Maintaining the physical Cryo-storages and products locations per SOP.
  • Work with vendors to evaluate new equipment and reagents.
  • Assist shipping/handling dept. for products packaging & delivery as needed.
  • Examine outgoing shipments to ensure shipments meet specifications.
  • Manage inventory of product as needed.
  • Environmental and quality control sampling
  • Review and sign off manufacturing final batch release.
  • Perform document overview to Pre-determine approval/rejection.
  • Lead Quality Control.
  • Data entry
  • Compliance with duties assigned to be followed in respect to ISO 9001, ISO/IEC 17025, ISO 20387, GLP, GDP, GTP and GMP defined responsibilities.
  • Review processes and direct manufacturing overview.
  • Registering products info. into database and batch records.
  • Perform documentations, verifying and keeping records on incoming and outgoing shipments.
  • Maintain current knowledge of relevant scientific literature.
  • Manage inventory of products, as needed.
  • General Aseptic Manufacturing and quality control duties

Requirements:

  • Bachelor’s degree in the biological sciences or any other related scientific field and a minimum of 2 years full-time laboratory experience in an industrial biomedical laboratory setting.
  • Experience in cell biology techniques, cell culture and cell isolation are required. The ideal candidate will also have additional experience in microscopy, histology, manufacturing, and tissue surgical techniques.
  • Experience in Auditing and Quality Control
  • Proficient in Aseptic and Sterility Techniques, assist in cell isolation, cell assays.
  • Knowledge and experience of GLP and/or GMP.
  • Knowledge and experience with Pipetting.
  • Knowledge and experience of developing and following SOPs.
  • Able to think creatively and solve problems.
  • Prior experience working in Strict Controlled environment- ISO 7 or ISO 5 (Class 100) cleanroom.
  • Very Detail-oriented
  • Strong written and oral communication skills
  • Ability to read and interpret documents such as blueprints, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively.
  • Dependability - Follows instructions; Takes responsibility for own actions; Commits to long hours of work when necessary to reach goals.
Company Descriptionwww.leocorps.orgCompany Descriptionwww.leocorps.org

  • Aliso Viejo, California, United States Leo Corps, Inc. Full time

    Job Description Job Description General Responsibilities include:Assist managers in registering bioprocesses info. into database.Follow Chief Scientific officer and quality assurance executives/management guidelines and expectations and tasks assigned.Assist with documentation, verifying and keeping records on incoming and outgoing shipments.Prepare all...


  • Aliso Viejo, United States Leo Corps, Inc. Full time

    Job DescriptionJob DescriptionGeneral Responsibilities include:Assist managers in registering bioprocesses info. into database.Follow Chief Scientific officer and quality assurance executives/management guidelines and expectations and tasks assigned.CAPA and deviation investigation and analysisAuditsOversees the entire quality process of the lab and...


  • Aliso Viejo, United States MicroVention Full time

    Job Description Production Support Focus Lead quality engineering projects to support the manufacturing of medical devices. Work with Manufacturing and R&D in leading efforts to resolve product quality issues. Support manufacturing process changes and product design improvements. Product Development Focus Lead quality engineering projects to support the...


  • Aliso Viejo, United States Spyglass Pharma Full time

    Job Description Job Description Salary: $175k/yr - $225k/yr About SpyGlass Pharma: At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug...


  • Aliso Viejo, United States Vertex Ventures HC Full time

    About SpyGlass Pharma: At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work...


  • Aliso Viejo, United States MicroVention Full time

    Work with R&D and Manufacturing to lead design control activities for the development and manufacture of medical devices and resolve product quality issues. Provide the quality/independent review at design reviews. Review and provide guidance for project design plans, risk management, design verification/validation, and process validation. Provide quality...


  • Aliso Viejo, United States Spyglass Pharma Full time

    Job DescriptionJob DescriptionSalary: $175k/yr - $225k/yrAbout SpyGlass Pharma:At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug...


  • Aliso Viejo, United States Leo Corps, Inc. Full time

    Job DescriptionJob DescriptionMonday-Friday (9:00AM-5:30PM), Weekend availabilityGeneral Responsibilities include:Assist managers in registering bioprocesses info. into database.Follow Chief Scientific officer and quality assurance executives/management guidelines and expectations and tasks assigned.Assist with documentation, verifying and keeping records on...


  • Aliso Viejo, United States RxSight, Inc. Full time

    Job Type Full-time Description RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world's first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company's mission is to revolutionize the premium cataract surgery experience by allowing surgeons...


  • Aliso Viejo, United States RXSIGHT INC Full time

    Job DescriptionJob DescriptionDescription:RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by...

  • Trainer, Quality

    3 weeks ago


    Aliso Viejo, United States MicroVention Full time

    Responsible for the design, development and delivery of quality training content and material. Assist with selection and creation of training effectiveness checks.Responsible for the evaluation of current training and the maintenance of all training. Job duties:Manage all training for MV quality systems.Conduct needs analysis. Create and implement training...

  • Trainer, Quality

    3 weeks ago


    Aliso Viejo, United States MicroVention Full time

    Job Description Responsible for the design, development and delivery of quality training content and material. Assist with selection and creation of training effectiveness checks. Responsible for the evaluation of current training and the maintenance of all training. Job duties: Manage all training for MV quality systems. Conduct needs analysis. Create and...

  • Lead Consultant, SRE

    2 weeks ago


    Aliso Viejo, United States Genpact Full time

    Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we...

  • Production Lead

    2 days ago


    Aliso Viejo, United States MicroVention Full time

    **12243BR** **Title:** Production Lead (2nd Shift) **Job Description:** Coordinates production activities to ensure materials, documents and processes are compliant with the established company practices and procedures. Performs the work in leadership position under moderate supervision from line Supervisor. Assists the Supervisor in all aspects of...


  • Aliso Viejo, United States Genpact Full time

    Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we...

  • Design Engineer II

    1 month ago


    Aliso Viejo, United States Fluor Full time

    At Fluor, we are proud to design and build projects and careers. This requires teams that are as unique as the projects we execute. We are committed to fostering a work environment that embraces Diversity, Equity, and Inclusion (DE&I) for all so our employees and stakeholders benefit from the creative solutions derived as a result of embracing...


  • Aliso Viejo, United States Ambry Genetics Corporation Full time

    **Compensation**: $25-$30/hr. You are eligible to a Short-Term Incentive Plan with the target at 5% of your annual earnings, terms and conditions apply. **Quality Assurance Specialist I (Hybrid/Onsite-Aliso Viejo, CA)** **Minimum of 2 days on site** **Job Overview**: **Essential Functions**: - Aid in execution of Supplier and Vendor Management Program...


  • Aliso Viejo, United States Century Group Full time

    Our client, a leading company in their respective industry, has recently secured several new contracts this year, marking an exciting phase of growth and opportunity. As they transition to a new ERP, they are seeking a highly skilled consultant to join their team and play a critical role in facilitating a smooth and successful system transition. Exact...


  • Aliso Viejo, United States NeoGenomics Full time

    Description Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity.We believe in career development and...


  • Mission Viejo, United States Burlington Stores Full time

    **LOCATION** 28452 Marguerite Pkwy Mission Viejo CA US 92692 **Overview** If you want an exciting job with one of the largest off-price retail stores in the nation, join the Burlington Stores, Inc. team as a Shortage Control Associate Lead! **Overview**: As a Shortage Control Associate Lead, you will be responsible for mitigating theft and fraud in high...