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Qa Lab Team Leader

Company

CooperVision
Address , , Pr
Employment type FULL_TIME
Salary
Expires 2023-07-10
Posted at 1 year ago
Job Description
QA Lab Team Leader - JUA1768


Description


CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.



JOB TITLE: QA Lab Team Leader

DEPARTMENT: Quality

JOB SUMMARY
Accountable for laboratory daily activities coordination to assure process flow. Responsibilities are done in compliance with good laboratory practices, GMP, QSR, MDSAP, safety and environmental regulations.



ESSENTIAL FUNCTIONS
  • Provides training to Laboratory personnel on proper laboratory methods, procedures, and techniques.
  • Generates ECO and DCO for laboratory projects or improvements.
  • Prepares and submits documentation to Safety group for compliance, and to Calibration Team for new equipment calibrations, calibration extensions, and preventive maintenance.
  • Create and revise procedures
  • Support to validation activities such as: Protocols, Execution, Deviations, and Reports
  • Assists to Laboratory Leader as required.
  • Complies and Maintain 6S (ROLESS) in the laboratory. Performs periodically internal laboratory assessments to detect non-conformances
  • Assists management in SU’s non-conformance resolution, validation strategy development for new methods and New Technology (NT).
  • Generates, evaluates and investigates NCR's and assure to close in a timely manner.
  • Provides support in Internal and External audits.
  • Assists to suppliers; coordinate meetings related to and any necessary activities.
  • Generates purchase requisitions to ensure an update laboratory inventory for all laboratory activities.
  • Performs Calibration alert investigations.
  • Assures that the pronto files are prepared
  • Reviews documentation
  • Performs laboratory equipment’s validations and protocols, deviations, as well as required reports.
  • Coordinates laboratory daily activities to assure process flow.
  • Coordinates laboratory’s equipment preventive maintenance, calibration and data revision with the calibration area and outside contractors/vendors to ensure the completion of equipment preventive maintenance calibration.
  • Assures compliance with good laboratory practices, QSR, MDSAP, safety and environmental regulations.
  • Generates and conducts laboratory investigations and provides technical reports for laboratory situations and deviations.


POSITION QUALIFICATIONS
KNOWLEDGE, SKILLS AND ABILITIES

  • Good communication skills
  • Initiative and problem-solving skills
  • Teamwork oriented
  • Ability to read, writes, and comprehends instructions in both languages English/Spanish
  • Able to work overtime if necessary, with minimum supervision
  • Good interpersonal skills at all levels
  • Knowledge of QSR (Quality System Regulations), MDSAP, Good Laboratory Practices, Good Manufacturing Practices, safety and environmental regulations
  • Computer skills (i.e. Excel, Word, PowerPoint, etc.)
  • Good oral and written communication skills in both English and Spanish are a must
  • Highly motivated, self-starter, and responsible person
  • Strong leadership skills: be very clear when advising of job/priorities instructions
  • Advance mathematics skills (i.e. average, rounding rules, multiply, divide, add, subtract, percentage, linear regression, standard deviation, relative standard deviation etc.).
  • Good technical writing skills
  • Knowledge in chemistry instruments and troubleshooting (GC, HPLC, FTIR, UV/VIS, pH, Karl Fischer, etc.)
WORK ENVIRONMENT
  • Utilizes reading, writing, speaking skills, analytical capacity and judgment to solve problems
  • The noise level in the work environment is usually moderate
  • Applies communication skills to perform work and speaks clearly and persuasively in positive or negative situations
  • Incumbent could be exposed to fumes of chemicals.
  • Needs to walk, stand, use hands to finger, handle, or feel; sit and reach with arms; lift and/or move up to 50 pounds; requires close vision

EDUCATION

  • Bachelor’s degree in science with major in Chemistry


EXPERIENCE

  • Demonstrates Initiative and problem-solving skills. Good communication skills.
  • Experience in validations, engineering studies and laboratory investigations.
  • At least four (4) years of experience in medical devices or pharmaceutical industry and Chemical quality laboratory.
  • General knowledge of lab equipment’s
  • Strong leadership skills and Teamwork oriented.


Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran
Job: QA Operations
Primary Location: Puerto Rico-Juana Diaz
Organization: CVI Americas Manufacturing Operations (AMO)
Schedule: Full-time
Unposting Date: Ongoing