Qc Chemist And Lab Safety Specialist Jobs

Highly skilled chemist ( PhD-level) with broad experience in polymer chemistry

Preferably more than 5 years synthesis/polymerization research experience

Preferably interdisciplinary experience from production, regulatory, or supply chain

Fluent in English, oral and write/read communication skill

High level of understanding of customer Needs, good communication with other function

Work under the supervision of the Quality Control Department Manager, with guidance from the Conversion Department Supervisor and Leads.

Minimum age requirement of 18.

Ensure that all produced goods meet quality specifications and adhere to GMP (Good Manufacturing Practices) and SOP's (Standard Operating Procedures).

High school diploma or GED equivalent.

Accurate reading of a tape measure.

Self-directed and able to multitask.

Assist management to identify method gap, area for improvement and work on continuous improvement projects.

Performs general laboratory support activities including reagent preparation, sample management

In-depth knowledge and expertise in method transfers/qualifications/validations

Ensure the analytical testing and laboratory documentation meet cGMP and GDP requirements.

Minimum education required: Bachelor's degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry

Minimum experience required: 5 years in a laboratory setting with focus in analytical chemistry

1-2 years of experience working with Small Molecule/ Biologics/ devices

Quality testing of final drug product (API, Small Mol, Radiopharmaceutical)

Method development, and validation activities

BS/MS in Chemistry, or related field

Background in Analytical Chemistry(HPLC, GC, TLC, etc.)

Strong understanding of regulatory and cGMP compliance guidelines

Managing project teams specifically assigned responsibilities related to sampling, environmental chemistry, laboratory analysis, data validation, and/or data management.

Serving as prime point of contact with clients, management, and subcontractors.

Familiarity with analytical database management systems such as LIMS, Microsoft Access, SQL, Locus EIM, EQuIS, and GIS desired.

Working collaboratively with HGL's Chemistry manager for ensuring resources for chemistry technical operations.

Excellent verbal and written communication skills

Working knowledge of instrumentation used for environmental analysis (e.g., LC-MS/MS, GC/MS, ICP, GC-ECD, IC, etc.)

Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards and GMP requirements.

Executes notification to management when required by procedures or standards.

Develops equipment qualification protocols with appropriate guidance.

Verify (SPV) analytical data of other analysts within the lab as requested.

May perform holistic review of data for release of data from the laboratory.

Recognizes when a deviation from procedures, etc has occurred and initiates and participates in a Root Cause Investigation.

Minimum of 2 years of experience running Gas Chromatographs, FTIR and other trace chemical gas detection equipment.

Excellent communication skills and the ability to work with other people

Perform or assist with equipment calibrations

Analyze gas samples in cylinders

Perform incoming quality control on raw materials.

Ability to complete tasks in a goal-oriented manner and take direction to ensure successful completion

Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping and 5S activities, etc.

Involve in supply management to ensure there are sufficient reference standard, reagents, supplies prior to your testing.

3 years of hands on experience with HPLC and UV instrumentation and chromatographic software.

Follow current test methods and/or protocols to perform analytical testing.

Maintain compliance to data integrity and cGMP in QC lab in line FDA and ICH guidance.

May assist with troubleshooting of assay methods and equipment.

Good interpersonal skills that support working in a team environment.

Knowledge of Analytical techniques and ability to incorporate them into daily tasks.

Perform chemical testing following current USP, Standard Operating Procedures (SOPs), Test Methods (TM), and protocols

Be proficient in using standard laboratory equipment, including pH meters, balances, pipettes, viscometers, UV/VIS, FTIR, and auto titrators

Operate and maintain HPLC and GC systems and their related computerized software systems

Makes recommendations concerning the cause and resolution of equipment issues or malfunctions

Test purchased materials and/or Perrigo manufactured products per cGMP requirements and participate in laboratory investigations

Experience in a laboratory setting preferred.

Strong attention to detail, ability to follow written procedures, and strong communication skills required.

Experience in a laboratory setting preferred, but comprehensive training is provided.

Knowledge of Microsoft Excel and Word preferred.

Demonstrated critical thinking skills, attention to detail, and the ability to work independently and with others.

Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

Author or revise SOPs, qualification/validation protocols and reports.

AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR

High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience

Deep knowledge of GMP, SOPs and quality control processes.

Deep written and verbal communication skills.

This is a rotating shift position. Salary is based on qualifications and experience.

Knowledge of Analytical Chemistry preferred.

Perform Quality Control tests on finished products according to established procedures.

Review all analysis results with supervisor, and grade all finished lots when testing is complete.

Enter all data into the laboratory database system.

Retain all finished samples and keep the retain sample room well organized and clean.

Good analytical and problem-solving skills.

Ability to prioritize and manage multiple tasks/projects and meeting all required deadlines.

Excellent verbal and written communication skills and problem-solving skills.

Assess product specifications of company and its suppliers, and compare with the requirements of our customers

Effectively interpret and communicate analysis results within the context of the production facilities to maintain product quality.

All supplies required for testing

Undergraduate degree in Chemistry with laboratory experience preferred

Superior communication skills written, verbal and listening

Strong computer skills for laboratory instrumentation, LIMS, etc.

Experience working in a collaborative environment and independently

Provides guidance to clients for sampling protocols and procedures, analytical results, QA, and occupational exposure limits.

Perform other duties as assigned.

Assists users of analytical data (Management, technicians, and production) with the interpretation of the analytical results.

An understanding and experience in a variety of analytical techniques.

Strong troubleshooting experience of analytical instruments.

Takes leadership role in the assurance of safe laboratory operations and maintain quality of data generated.

Resolves quality issues including instrument reliability, accuracy, precision, turnaround time, capability, and value.

Works with the Analytical/PT group to develop new or improved analytical methods or new methodologies.

Experience working in a regulated laboratory environment (GxP) is desirable.

Experience with counting colonies on agar plates is desirable but not required.

Benefits of Working in ICON:

Interpreting and data processing/reporting results and approve or reject sample analysis

Perform peer review of technical documents for accuracy, thoroughness and regulatory compliance.

Perform glassware washing, reagents and solutions preparation, and general laboratory cleaning.

Determine re-testing parameters and prepare the OOS reports under management approval.

Maintain accuracy and completion of these documents under management approval.

Coordinate with management to determine testing timeframes and schedule to ensure projects are completed on time.

Participate in methods development, validations, and certification activities.

Bachelor’s degree and or experience in related field.

3-5 years’ experience working in a laboratory environment.

Perform any other tasks/duties as assigned by management.

Knowledge and familiarity of equipment including HPLC/GC instrumentation, Atomic Absorption, UV/Vis and FT/IR Spectrophotometers.

Excellent organizational, interpersonal and communication skills (written and oral) required.

Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.

Responsible for performing routine testing on raw materials and/or finished product pharmaceuticals in compliance with cGMPs.

Execute wet chemical and analytical methods to assess the purity, potency and stability of drug substances and finished products.

Specific experience with LIMS (Laboratory Information Management System) is preferred.

Related experience in a pharmaceutical, GMP, or FDA regulated testing laboratory is preferred.

Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.

Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.

Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.

Excellent verbal and written communication skills in the English language.

Perform simple identification of various chemicals or formulations as per methodology USP/NF and other test requirements

Basic understanding of the requirements of the USP and GMP requirements as applied to the testing of pharmaceuticals.

Performs routine maintenance activities in the laboratory and participates in the qualification and periodic calibration or verification of equipment.

Must have good communication skills.

Knowledge of Analytical techniques and able to incorporate them into daily tasks.

Good interpersonal skills that support working in a team environment.