Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • UNITED STATES OF AMERICA - NEW JERSEY - BRANCHBURG

Description

Senior Laboratory Technician
Quality Operations
1st Shift
The suitable candidate works under general supervision to perform Quality Control sampling and microbiological and chemical based testing of environmental samples using established procedures and technical and theoretical understanding.
Job Description:
Sample collection, sample handling and testing of environmental samples
Data entry and analysis, validation of data
Assumes responsibility for the accuracy, quality and timeliness of results
Evaluation of results and trends
Document authoring and review
Awareness and adherence to cGMP, GLP, other regulations
Performs tasks according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g. OSHA)
Participates in routine lab maintenance, routine cleaning, instrument maintenance, lab safety
Job-related Experience:
1. Knowledge of general laboratory practices/skills (focus in microbiology):
Aseptic Technique – sampling, testing
Microbiological sample handling (bacteria, mold)
Pipetting
Streaking plates for isolation/microbial identification
Understanding of incubation times/temperatures for common microorganisms
2. Past experience with sampling/testing of Environment, Water, Clean Steam:
Viable/Nonviable Air, Viable Surface
Chemical Testing: Total Organic Carbon, Conductivity, Chlorine, pH
Vaccuum (micro) filtration
Growth Promotion testing of microbiological media
3. Understanding of regulatory agencies and knowledge of current industry standards/directives (USP, ISO)
4. Working experience with a GMP/GLP Laboratory environment is highly desirable.
5. High proficiency of computers/data entry (EXCEL, Word, SAP):
Understanding of basic EXCEL formulas, filtering, macros and other program capabilities
Capable of independent troubleshooting
Generating tables/graphs for trending/reporting
Understanding of Word formatting, redlining
Familiarity with Powerpoint presentation

General Duties:
1. Perform sampling and testing as required to meet Operations goals and objectives with some direction and collaboration with supervisor.  Specifically, this includes the following:
Sampling and testing of environmental samples including all data entry within the allotted Turn Around Times with focus on document returns, error rates, and human error
Entry of data into trends and evaluation of trends within the allotted Turn Around Times
Validation of data
Able to interpret data based on data and analysis and make decisions with collaboration with supervisor as applicable
Awareness and compliance to cGMP, GLP, GDP and other regulations.  When necessary, escalating non-compliance to these regulations
Overseeing and participating in laboratory maintenance including routine cleaning, instrument maintenance and maintaining laboratories in audit ready condition.  Able to identify improvements and implement with collaboration from supervisor. 
Participating in validation activities including Process validation, Test Method transfer or validation and Equipment Performance Qualification as required
2. Complete all required training in learning solution and/or as specified by your manager on time to remain compliant. This includes managing both GMP and competency/skill code training.  Additional training should be performed as required by business need and/or individual development.
3. Responsible for training other laboratory analysts, as applicable in a professional manner to ensure that business needs are being met.
4. Ability to work day to day with some supervision to correctly complete daily scheduled and unscheduled testing related activities. Initiates daily activities independently.  When issues arise collaborate with supervisor to develop solutions.  Decision making with collaboration from supervisor is required. Decisions do not negatively impact service, quality or finances; ensures that mindfulness to service, quality and finances goes into decision making process even in an ambiguous situation. 
5. Participate in audits as applicable.
6. Participate and implements process improvements to meet business needs and effectively communicates all process improvement ideas centralized around product delivery, cost and quality.  Able to link responsibilities with both RMD and Global Operations with collaboration from supervisor.  Focuses on activities that provide the most value with direction from supervisor.
7. Document authoring and review, as required

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

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