Quality Control Associate II

Full Time
Oceanside, CA 92056
Posted Today
Job description
THE POSITION

Perform adventitious agent testing in support of manufacturing operations, lot release and validation in accordance to standard operating procedures. Collect, process, and report data. Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis. Conduct routine and non-routine analysis of manufactured products. Calibrate and maintain laboratory and instrumentation equipment. Revise and update standard operation procedures. Develop and/or optimize testing methods and troubleshoot testing methods. Maintain laboratories in audit ready and cGMP compliant manner. Compile data for documentation of test procedures and prepare reports for internal and regulatory submissions. Review and evaluate data for conformance to specifications/reports. Investigate anomalous data. Use state-of-the-art techniques to evaluate and implement new techniques and technologies. Maintain validation program for QC laboratory analytical instruments. Evaluate and trend data and discrepancies. Provide ongoing training and process improvements. Support product operations with special projects.

Job Responsibilities

Essential

  • Collect, process and report on data for samples associated with in-process testing from the clinical and/or commercial manufacturing facilities
  • Initiate, compile, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information
  • Apply advanced techniques to troubleshoot assay and equipment problems
  • Perform adventitious agent testing at all levels of complexity to support manufactured products, investigations, special studies, and validations
  • Train others in basic to complex laboratory and troubleshooting techniques
  • Serve as a liaison for daily activities and special projects within QC or cross-functionally
  • Act as subject matter expert for assays/areas of technical expertise and provide support to analysts within department and cross-site
  • Perform data review, data trending, report writing, and lab maintenance
  • Evaluate and implement new techniques and technologies
  • Participate in routine projects
  • Responsible for working independently as well as within a team
  • Responsible for collecting, entering data and generating reports from electronic systems
  • Manage QC user administration requests for laboratory systems
  • Perform day-to-day administration tasks using laboratory systems
  • Identify and train in other applications or assays as necessary to support QC activities as a subject matter expert
  • Identify functional improvement needs for laboratory systems or technical equipment
  • Lead projects requiring technical or project management guidance
  • Apply theories and principles from technical and/or professional discipline to independently address a variety of problems of moderate scope.
  • All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
  • Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

  • Act as designee in cross-site and/or interdepartmental meetings
  • Facilitate team meetings as required
  • Attends department and corporate meetings
  • Attends seminars and/or classes to enhance technical or professional skills

Job Requirements

Education and Experience

  • Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline
  • 5-6 years of related experience

Knowledge, Skills, and Abilities

  • Demonstrate excellent organizational skills
  • Strong written and verbal communication skills, with demonstrated leadership in a large group
  • Computer skills- LIMS, Microsoft Word, Excel, Power Point, Visio
  • Ability to read and follow Standard Operating Procedures
  • Work under general supervision and guidance
  • Ability to read and interpret technical data
  • Ability to work in a fast pace environment with high volume testing schedules
  • Experience in chemical and microbiological testing assays
  • Excellent aseptic technique
  • Experience with electronic systems used in laboratories
  • Detail-oriented
  • Knowledge of laboratory safety procedures
  • Experience working in GMP environment
  • Experience speaking to auditors

Work Environment/Physical Demands/Safety Considerations

  • Work in office and laboratory environment
  • Lift up to 30lbs
  • May work in the clean room environment that requires gowning and no make up or jewelry
  • May work in the clean room environment where it is loud due to different equipment operating
  • Work with some hazardous materials and chemicals
  • Ability to sit, stand and move within work space for extended periods
  • Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling.
  • Ability to stand 8 to 10 hours a day.

Relocation Assistance is not available for this position.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

JOB FACTS
    Job Sub Category

    Quality

    Schedule

    Full time

    Job Type

    Regular

    Posted Date

    Aug 2nd 2022

    Job ID

    202205-120926

Intrested in this job?

Related Jobs

All Related Listed jobs

Hyatt Regency Chicago Chicago, IL 60601 Today

Resumen El candidato debe tener fuertes habilidades en electricidad (resolucin de problemas y arreglo de equipos elctricos y otros equipos asociados, conocimiento de planos y diagramas de

Two Barrels Spokane, WA Today

Overview: Two Barrels is hiring a Software Automation Engineer for $55,000/year. You will be a traditional company employee. This is a full time 40 hour M-F position with company benefits in Spokane,

UVMHN Home Health & Hospice Burlington, VT 05405 8 days ago

Primary Shift: 8:30 AM - 5:00 PM. External candidates are eligible for a one-time signing bonus of $4,000 (prorated for part time roles).

Best Buy Liquors Brooklyn, NY 11224 Today

please send your resume to [email protected] Replenishment of shelves and displays Must be able to handle deliveries of 100 case+ of product Able to lift 40lbs cases

QC Kinetix Chandler, AZ 85286 $300 - $1,000 a day 30+ days ago

Looking for a Part Time DO/MD for Regenerative Medicine Focusing on Musculoskeletal joint pain. Job consists mainly of initial exams with patients, Highly

University of Alaska Anchorage, AK 99508 Today

Job Number:521136 Classification:Student Assistant 2 Grade:Student Assistant 2 Work type:On Campus, Student Employee

Colliers International Salt Lake City, UT 30+ days ago

Were looking for stellar construction project managers who are super organized, have a keen eye for the details and have managed and assisted in complex

PSA Airlines Pensacola, FL 32504 Today

Overview: Maintenance Supervisor Location: Pensacola, FL Work Schedule / Shift Reports To: Maintenance Manager Relocation: Assistance available Let your career

ActioNet Washington, DC 20001 Today

ActioNet has an immediate opportunity for a Application Packager/ Analyst requiring a Public Trust who will primarily work remotely but go onsite at one of the FAA Tech Centers as needed (Atlantic

First Transit Cincinnati, OH 45202 Today

First things First: Who are we? First America is the largest passenger transportation company in North America, we provide passenger transport and maintenance services to municipalities, school