QA Technician I
23 hours ago
**Work Schedule**Second Shift (Afternoons)**Environmental Conditions**Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials**Job Description****Work shift:****Monday through Friday****1:00 pm to 9:30 pm****Summary:**Carry out the sampling of packaging components and raw materials according to current Good Manufacturing Practices (GMP) and all applicable Patheon Standard Operating Procedures (SOPs).Complete testing and release of Packaging Components.Inspect/test In-Process materials (i.e. tablets/capsules).**Essential Functions:**Sample and perform all in-house physical testing of packaging components and raw materials which requires use of forklift and subsequent cleaning/sanitizing of the sampling room.Identify Raw Materials using RamanCoordinate and perform calibration of equipmentPerform physical testing of bulk productsPerformAdministrative duties as follows:Movement of materials within SAPfrom quarantine into release, reject, or hold statusLabel materials for release / expire / re-test statusSubmitting, tracking and transportation of samplesLog in retains / sample retainsReviews packaging components/ Infrared (IR) scans/ Physical Testing resultsMaintain a safe working environment and reports potential hazards.Perform alternating or rotating shift work (as required)**REQUIRED QUALIFICATIONS****Education:**High school diploma/General Educational Development (GED) Certificate is required**Experience:**No previous work experience required.Preferred: Experience in a QA or QC or related fieldPreferred: Experience in a cGMP environmentPreferred: Experience with SAPPreferred: Experience using a Forklift**Equivalency**_:_Equivalent combinations of education, training, and relevant work experience may be considered.**Knowledge, Skills and Abilities****:**Detail oriented individual with excellent organizational skills.Good verbal and written communication skills. Ability to work well independently and in a team environment.Knowledge of Good Manufacturing Practices and Standard Operating Procedures.Good understanding of safety standards.Microsoft Office skills in Word and Excel.Proficiency with the English language.**Standards and Expectations:u202fu202f** u202fFollow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP''s and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.u202f Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems,u202fetc.). Be client and patient consciousu202fat all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner.u202f Consistently strives to improve skills and knowledge in related field. u202fu202fu202f**Physical Requirements:**Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.**Disclaimer:**This job description is intended to present the general content and requirements for the performance of this job.The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements.Managers and supervisors may assign other duties as needed.Nothing contained herein should be construed to create an employment contract.Occasionally, required skills/experiences for jobs are expressed in brief terms.Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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