Lab Analyst - Microbiology Job at Bureau Veritas Certification CZ, s.r.o. (Hodges)

Analyst III, Quality Lab-Microbiology

This position is responsible for conducting microbiological in support of manufa...

Location

United States , Hayward

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

B.S. degree in Microbiology, Biology, or related science experience
with minimum of 5 years' experience, or Master's Degree in Chemistry or biological science with 1-4 years' experience
Knowledge of microbiology and environmental monitoring (Endotoxin, Bioburden, and EM monitoring test)
Demonstrates some knowledge of assays/equipment in functional area
Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office)
Proficient use of laboratory equipment and tools
Must be detail-oriented, conscientious, and responsible
Must have effective verbal and written communication skills
Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations application of CGMP/GDPs
Must be able to learn new computer systems and programs in a timely manner

Job Responsibility

Conduct Microbiological analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility
Testing as required supporting Endotoxin testing, Bioburden analysis, microbial identifications, biological indicators, growth promotion, water
Will be required to read microbial plates and interpret test results
Perform microbial and particulate monitoring of clean rooms throughout the facility. May be responsible for overseeing daily workflow of assigned area
Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in cleanrooms
Perform equipment maintenance and calibrations as required
Maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation
Write and execute validations for manufacturing processes and laboratory instruments and methods
Work on special projects / protocol testing that involves new methods and instrumentation. Complete all testing, including special project / protocol testing in a timely and appropriate manner
Investigate deviations and write nonconformance documents

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Analyst Iii, Quality Lab-Microbiology

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Hayward

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

B.S. degree in Microbiology, Biology, or related science experience
with minimum of 5 years’ experience, or Master’s Degree in Chemistry or biological science with 1-4 years’ experience.
Knowledge of microbiology and environmental monitoring (Endotoxin, Bioburden, and EM monitoring test)
Demonstrates some knowledge of assays/equipment in functional area. Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
Proficient use of laboratory equipment and tools. Must be detail-oriented, conscientious, and responsible. Must have effective verbal and written communication skills. Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations application of CGMP/GDPs.
Must be able to learn new computer systems and programs in a timely manner.
Strong leadership, organization and time management skills.
Attention to detail and ability to prioritize multiple tasks in a timely manner.
Effective organizational skills and ability to plan and suggest resolutions to technical problems.
Strong data analysis and report writing skills.

Job Responsibility

Conduct Microbiological analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.
Testing as required supporting Endotoxin testing, Bioburden analysis, microbial identifications, biological indicators, growth promotion, water.
Perform microbial and particulate monitoring of clean rooms throughout the facility.
Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in cleanrooms.
Perform equipment maintenance and calibrations as required.
Maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation.
Write and execute validations for manufacturing processes and laboratory instruments and methods.
Work on special projects / protocol testing that involves new methods and instrumentation.
Investigate deviations and write nonconformance documents
Lead and/or actively contribute to a team setting within the laboratory to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Analyst III, Quality Lab-Microbiology

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Hayward

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

B.S. degree in Microbiology, Biology, or related science experience
with minimum of 5 years’ experience, or Master’s Degree in Chemistry or biological science with 1-4 years’ experience
Knowledge of microbiology and environmental monitoring (Endotoxin, Bioburden, and EM monitoring test)
Demonstrates some knowledge of assays/equipment in functional area
Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office)
Proficient use of laboratory equipment and tools
Must be detail-oriented, conscientious, and responsible
Must have effective verbal and written communication skills
Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations application of CGMP/GDPs
Must be able to learn new computer systems and programs in a timely manner

Job Responsibility

Conduct Microbiological analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility
Testing as required supporting Endotoxin testing, Bioburden analysis, microbial identifications, biological indicators, growth promotion, water
Will be required to read microbial plates and interpret test results
Perform microbial and particulate monitoring of clean rooms throughout the facility
May be responsible for overseeing daily workflow of assigned area
Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in cleanrooms
Perform equipment maintenance and calibrations as required
Maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation
Write and execute validations for manufacturing processes and laboratory instruments and methods
Work on special projects / protocol testing that involves new methods and instrumentation

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Qc Analyst Ii, Microbiology

We are looking for an enthusiastic Microbiology Analyst to support the cGMP Qual...

Location

Canada , Vancouver

Salary:

78200.00 - 92000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

5+ years of QC experience in addition to a Bachelor’s degree
Master’s degree in a relevant scientific discipline and 3+ years of QC experience
Strong knowledge and experience in Good Manufacturing Practices (GMPs), QC microbiological testing and method qualification requirements
Experience with using Milliflex Oasis, Charles River Endosafe nexgen-MCS, LIMS, as well as basic benchtop techniques such as Gram staining, plate reading, vacuum filtration and LAL gel-clot
Excellent interpersonal skills, ability to work independently and in a team environment, detail oriented, organized and methodical in execution of tasks
Ability to problem solve with sound analytical thinking

Job Responsibility

Providing microbial support for aseptic product manufacturing in a cGMP regulated environment
Performing site support activities such as environmental monitoring, compressed gas and water system sampling within the graded manufacturing area
Planning, scheduling, and coordinating microbiological sampling and testing activities to support manufacturing operations, including routine monitoring, batch-related testing, and time-critical samples, ensuring alignment with production schedules and testing timelines
Carrying out a variety of routine microbiological techniques on utilities including but not limited to bioburden, endotoxin, TOC, conductivity and growth promotion testing on incoming microbial media
Responsible for micro release testing on raw materials, in-process drug substance and final product samples
Evaluating and reviewing test results for conformance to appropriate specifications and highlighting any suspect results to the QC Lab Manager
Participating in identification, investigation (deviations/out of specifications) and resolution of problems in the microbiology lab
Authoring method verification protocols, SOPs, WIs and TMs based on industry standard compendial methods

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Teams and social groups to build community and connections

Fulltime

Analyst II, Quality Control Microbiology

The incumbent will support the implementation and execution of core microbiology...

Location

United States , Durham

Salary:

70000.00 - 115000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in a scientific discipline
2+ years' relevant experience in the pharmaceutical/biotech industry
Excellent verbal and written communication skills
Strong writing skills
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work equally well individually as within a multi-disciplinary team
Excellent time management skills
Consistent delivery of high-quality work at all times

Job Responsibility

Draft documentation for the microbiology programs (SOPs, WIs, Protocols, reports etc.)
Conduct and draft investigations for the microbiology programs (EM excursions, lab deviations, product OOS's, etc.)
Support the implementation and execution of microbiology laboratory programs, including bioburden, endotoxin, and rapid sterility testing, method verifications, media growth promotion and gram staining
Support the implementation and execution of the environmental monitoring (EM) program
Review and approve laboratory data for the microbiology programs
Support the incoming testing and management of raw materials
Assist with the data analysis and trending program for EM data
Support the implementation of the disinfectant efficacy qualification program
Partner with CQV representative to support the implementation of QC lab equipment by providing technical assistance during the development and execution of IQ/OQ/PQ protocols
Provide assistance for the implementation of the site LIMS

Fulltime

Lead Epic Systems Analyst - Beaker, Technology & Digital

The Lead Business Systems Analyst applies analytical processes to the planning, ...

Location

United States of America , Coral Gables

Salary:

96682.12 - 125686.76 USD / Year

Baptist Health

Expiration Date

Until further notice

Requirements

Bachelor's degree in Computer Science, MIS, Information Sciences or related discipline or equivalent work experience
Epic Beaker Experience
Epic Beaker Certified
Experience in medium sized, fast paced corporate organizations
Self-motivated, ability to learn new concepts/job requirements
Proven project leadership skills for medium to large scale projects
Budget forecasting capabilities, ability to deliver on time and on budget
Basic skills in vendor management, risk mitigation
Basic system vulnerability management competencies
Knowledge in Structured Query Language (SQL)

Job Responsibility

Lead and support the implementation of Epic Beaker CP and AP modules, including build, configuration, and validation
Collaborate with laboratory leadership, pathologists, and IT teams to gather requirements and translate them into system specifications
Design and optimize workflows for specimen collection, processing, analysis, and reporting
Orders and collection, resulting workflows, results routing, interfaces and reference labs, charging and access, reporting
Microbiology, General Laboratory, and Anatomic Pathology workflows
Perform system testing, validation, and troubleshooting to ensure data integrity and system performance
Develop and maintain documentation, including build specifications, test scripts, and training materials
Provide go-live and post-implementation support, including issue resolution and system enhancements
Ensure compliance with HIPAA, CAP, CLIA, and other regulatory requirements
Participate in on-call rotation and provide after-hours support as needed

What we offer

Career growth and development opportunities
Comprehensive health and wellness resources
Wellness program that can help eliminate medical plan deductible
Tuition reimbursement
And so much more

Fulltime

Lead Epic Systems Analyst - Beaker

The Lead Business Systems Analyst applies analytical processes to the planning, ...

Location

United States , Coral Gables

Salary:

96682.12 - 125686.76 USD / Year

Baptist Health

Expiration Date

Until further notice

Requirements

Bachelor‘s degree in Computer Science, MIS, Information Sciences or related discipline or equivalent work experience
Epic Beaker Experience
Epic Beaker Certified
Experience in medium sized, fast paced corporate organizations
Self-motivated, ability to learn new concepts/job requirements
Proven project leadership skills for medium to large scale projects
Budget forecasting capabilities, ability to deliver on time and on budget
Basic skills in vendor management, risk mitigation
Basic system vulnerability management competencies
Knowledge in Structured Query Language (SQL)

Job Responsibility

Applies analytical processes to the planning, design & implementation of technology systems to meet business requirements
Leads multiple mid-large size implementations & initiatives
Modifies systems including encoding, testing, debugging & installing support application systems
Formulates measurable & actionable approaches to accelerate implementation through optimized or established operational workflow & processes
Partners with operations to ensure business ideas are translated into requirements with clear & measurable outcomes
Works with others to identify, research, & evaluate enterprise applications & technologies to promote strategic Technology & Digital initiatives
Translates business needs to technical requirements, optimizing existing implementations & debugging reported issues
Manages & leads others through change
Provides & supports the implementation of business solutions by building partnerships with key stakeholders, identifying business needs, determining & carrying out necessary processes & practices, monitoring progress & results, recognizing & capitalizing on improvement opportunities & adapting to competing demands, organizational changes & new responsibilities
Lead and support the implementation of Epic Beaker CP and AP modules, including build, configuration, and validation

Fulltime

QC Analyst II

Performs analyses of Clinical Chemistry, Critical Care, Coagulation and/or Micro...

Location

United States , Orangeburg

Salary:

24.00 - 29.00 USD / Hour

werfen

Expiration Date

Until further notice

Requirements

B.S./B.A. Degree in Science or Medical Technology or equivalent required
2 years clinical laboratory experience with a basic knowledge of quality control principles
ability to lift and move materials per current OSHA standards

Job Responsibility

Performs automated and manual assays as detailed in departmental/plant SOPs and QC Monographs including raw material, in-process and finished product
Interprets test results against specifications and decides if assays pass or fail
Maintains documentation of all work performed in accordance with GMP requirements
Evaluates product complaints upon Team Leader or Team Champion's request
Performs product stability, proficiency, environmental testing and water system testing
Responsible for routine preventive maintenance, general trouble shooting, general cleanliness and calibration of Lab equipment
Updates departmental SOP's and QC Monographs as directed by Team Leader or Senior QC Analyst
Performs microbial testing per SOP's and QC Monographs
Orders required laboratory supplies, reagents and other consumables
Monitors proper storage conditions and expiration dates

Fulltime

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Lab Analyst - Microbiology

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