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Senior Metrology Technician

BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, California, United States of America Req #80
Tuesday, April 5, 2022
At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

ThSenior Metrology Technician is responsible for providing quality oversight of equipment qualifications and maintenance. He or she is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success and meets business needs.

 

Essential Responsibilities

  • Performs and maintains documentation and compliance standards with adherence to USFDA, OECD and MHLW Good Laboratory Practices regulations, as required
  • Performs all routine and non-routine maintenance for all instrumentation and equipment; performs troubleshooting activities and repairs equipment and instruments
  • Coordinates installation and training for new equipment and instrumentation
  • Maintains parts and supplies for all equipment and instrumentation
  • Performs IQ, OQ, and PQ on all HPLC and LC/MS/MS chromatographic instruments and non-chromatographic instrumentation used for data acquisition
  • Conducts measurement systems analysis, including but not limited to precision to tolerance, accuracy, repeatability and reproducibility, linearity, bias, and stability to ensure the quality of the systems; prepares data for review by management
  • Characterizes equipment capabilities and performs calibration analysis prior to release of equipment into active use; this includes but is not limited to detecting and eliminating sources of variation and error, ensuring the quality of output data, and calibrating and repairing handheld measuring instruments
  • Creates and/or updates Standard Operating Procedures (SOPs) for equipment and analytical instruments
  • Responsible for overseeing vendors to facilitate installation, maintenance, performance monitoring, and repair of instruments; this includes but is not limited to maintenance of all calibration certificates
  • Maintains all equipment databases containing information
  • Assesses the validity of previous test inspections for out of control and out of specification calibration readings
  • Responsible for equipment management programs as well as working with other departments/consultants/vendors to plan, implement, and complete all validation/qualification projects
  • Responsible for the maintenance of the Equipment Master Listing
  • Reviews and approves equipment out of tolerances investigations
  • Perform duties with minimal Management oversite
  • Other duties as assigned

Minimum Acceptable Qualifications
 

Education/Experience:

  • Bachelor's degree in engineering, biological science, or related discipline
  • Not less than five (5) years' experience in pharmaceutical/GxP/regulated environment

Skills

  • Demonstrated experience with analytical instrument and/or equipment qualifications
  • Demonstrated experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO)
  • Working knowledge of Sciex and/or Waters instrumentation and software
  • Knowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles
  • Ability to apply validation principles to the design and implementation of projects
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies
  • Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
  • Advanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)
  • Excellent written and verbal communication skills
  • Versatility, flexibility, and willingness to work within constantly changing priorities
  • Ability to deal effectively with a diversity of individuals at all organizational levels
  • Project management skills not required, but preferred

Working Environment

  • Primarily a laboratory/clinical and office environment
  • Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Physical Demands

  • Ability to work in an upright and/or stationary position for more than eight (8) hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office and lab equipment
  • Frequent mobility required
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
  • Light to moderate lifting and carrying (or otherwise moves) objects including equipment, files, and laptop computer with a maximum lift of 20 pounds
  • Ability to access and use a variety of computer software
  • Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Frequently interacts with others to obtain or relate information to diverse groups
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
  • Ability to perform under stress and multi-task
  • Regular and consistent attendance

Position Type and Expected Hours of Work

  • This is a full-time position
  • Some flexibility in hours is allowed, but the employee must be available during the "core" work hours as published in the BioAgilytix Employee Handbook
  • Occasional weekend, holiday, and early morning/evening work required
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Paid Holidays (9 scheduled; 3 floating), 401k with Employer Match Employee Referral Program (up to $10k), Free Coffee, Tea, Fruit, and Snacks, Discounted Vending Machines (25 cents for everything!), Team Wellness Challenges/Events 
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

Other details

  • Pay Type Salary
Location on Google Maps
  • BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, California, United States of America