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Quality Technician-Senior

Posted 4 days ago

  • Sector: Scientific
  • Contact: John De Los Reyes
  • Contact Email: jreyes@staffing-the-universe.com
  • Contact Phone: 7323534217
  • Start Date: 01/04/2021
  • Job Ref: 21-00339
Summary of Position
Perform basic intermediate or advanced quantitative and qualitative analyses of pharmaceutical components inprocess material finished good product andor stability product Depending on the department to which the incumbent reports some of the functions listed may not be applicable

Job Results Essential Functions
Samples Tested
A Performs basic analytical laboratory tests such as potency purity uniformity dissolution moisture etc in accordance with approved methodology and cGMP FDA and DEA regulations including
a Performs setups adjustments calibrations and operation of laboratory equipment and instruments as well as any associated software
b Prepares solutions solvents and mobile phases
c Accurately prepares collecst weighs and analyzes samples and reference standards and determines conformance of results to approved specification limits
B Independently performs basic investigations for outofspecificationoutoftrend results
Documentation Completed to Standards
A Provides accurate and timely documentation of all procedures calculations and results
Department Specific Functions Completed to Standards
A Completes LIMS entry approvals and data release of products
B Uses analytical balances HPLC GC KF Titrator IR UV pH Meter volumetric glassware
C Performs wet testing like assay titrations colorimetric tests TLC heavy metals and sieves
D Flexes skills to other laboratories based on business need
E Follows established procedures using own discretion and judgment as to the specific approach or technique
F IdentifiesResearches new lab supplies and ordering current lab supplies
G Identifies and implements cost saving opportunities
H Sustains laboratory housekeeping and identifies improvement opportunities
I Completes handson and electronic training
J Participates and leads area huddles or shift meetings
K Performs other duties as assigned
QC Tech I Performs basic wet chemistry preparation of reagentssolutions and sample reconciliation following approved methods
QC Tech II Experienced at some instrumentation and wet testing
QC Tech III Expert in wet chemistry analysis and instrumentation analysis performed by laboratory Ability to perform some instrument maintenance and troubleshooting chromatography issues Trainer for areas of proficiency Perform peer review and release of all products participate in validations and execute Gage RR experiments Initiates and supports Out of Specification Out of Trend and Exception Investigations Identify method improvements and perform change controls Regularly uses communication skills to exchange information especially technical information within the lab and with other departments

Key Competencies
Attention to DetailFocus Is thorough and precise in accomplishing a task through concern for all the areas involved no matter how small Monitors and checks work or information and plans and organizes time and resources efficiently Doublechecks the accuracy of information and work product to provide accurate and consistent work Provides information on a timely basis and in a usable form to others who need to act on it Compares observations of finished work to what is expected to find inconsistencies
Listening Practices attentive and active listening has the patience to hear people out can accurately restate the opinions of others even when heshe disagrees
Follows Processes Consistently Shows concern for all aspects of the job by accurately checking processes and tasks carefully and accurately follows established procedures for completing work tasks uses knowledge that is acquired through formal training or extensive onthejob experience to perform ones job
Problem Solving Rigorously and systematically connects information processes and events by organizing divergent information and searching for common themes patterns and causal connections Undertakes a complex task by breaking it down into manageable parts in a systematic detailed way Thinks of several possible explanations or alternatives for a situation and anticipates potential obstacles and develops contingency plans to overcome them Uses intelligence common sense hard work and tenacity to solve particularly difficult or complicated challenges
Analytical Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions uses logic mathematics or other problemsolving tools in data analysis or in generating solutions logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand thinks in terms of generalized models rather than concrete details
Technical Learning Picks up on technical things quickly can learn new skills and knowledge is good at learning new industry company product or technical knowledge does well in technical courses and seminars

Minimum Requirements
Education
High School Diploma or equivalent required Bachelor Degree in science related field Chemistry Biology is preferred or Associates Degree with equivalent combination of education experience and competencies accepted
Experience
Tech I Classroom or previous work experience in a science related field
Tech II Working knowledge of chemistry required
Tech III Minimum 13 years of experience in a cGMP facility
Preferred SkillsQualifications
Perform basic functions of arithmetic add subtract multiply and divide all units of measure
Perform reading writing and speaking at a basic level
Basic computer skills including Word Excel and database software
Ability to understand and apply cGMP SOP and DEA regulations
Ability to deal with and solve problems of moderate difficulty
Selfmotivated demonstrates initiative able to make good decisions under pressure
Possess sufficient interpersonal skills to be able to function as part of a team
Attention to detail and accuracy
Ability to learn and apply technical concepts rapidly
Other SkillsCompetencies
Comply with company policies and procedures
Follow safe working practices in the execution of assigned duties
Participate in general site and departmental safety initiatives

Physical DemandsWork Environment
PhysicalVisual Activities or Demands Physicalvisual activities or demands that are commonly associated with the performance of the functions of this job
1 The job involves sitting walking and standing reaching talking and hearing Job requires to exert a negligible amount of force continuously and up to 50 pounds of force occasionally to lift carry push pull or move objects
2 Depending on task will be on standing or moving majority of the day Some tasks will require sitting a deskbench performing work on a computer
3 The job involves the ability to judge distance and space relationships identify and distinguish colors and bring objects within 20 inches into clear focus
4 Flow of work and character of duties involves focused mental and visual attention much or all of the time
EnvironmentalAtmospheric Conditions commonly associated with the performance of the functions of this job
Typical laboratory work environment Exposure to pure chemicals raw materials and product requires safety precautions and use of lab coat safety glasses gloves dust maskrespirator safety shoes andor booties as outlined in MSDS Work hazards include proximity to chemicals and solutions exposure to dust odors cleaning solvents noise vibration and poor ventilation Some elements present that make conditions less desirable than usually found in an office environment