Chemist ; overnights Job Woodstock area,Illinois USA,Quality Assurance

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Woodstock, IL, US

3 days ago Requisition

Salary: $58,000.00 Annually

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package.
This position will be scheduled to work Sunday - Wednesday, 7:00PM - 5:30AM (4days x 10.5 hours) and is eligible for a 10% shift premium for the overnights.

I.

Position Overview:

The position is responsible for testing Cleaning, Raw Material Water, In-Process and Finished Product samples. Supports laboratory investigations, system testing and process validation and business development activities.

II.

Specific Duties , Activities, and Responsibilities:

Completely, accurately and precisely prepares all laboratory reports and/or test scripts and documents in accordance with cGDP and cGMP requirements
Demonstrates high ethical standards
Maintain current training status on relevant equipment and procedures
Comply with all cGMP, regulatory and corporate and EHS requirements
Demonstrates ability to multi-task and prioritize work
Maintain laboratory in audit readiness per cGDP and cGMP practices
Perform peer review for testing and calculations, as necessary
Recognizes Out of Specification, atypical and/or anomalous data, escalates to management, as necessary
Maintain effectiveness of the Quality System components relevant to this position.
Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
Other duties as assigned.

Laboratory

Skills:

Perform analytical testing and calculations on in-process bulk material, finished product, cleaning and customer samples
Receive and prepare reagents and standards
Perform Rinse Water testing: TOC, Conductivity
Perform Raw Material Water testing:
Nitrates
Operate analytical instrumentation
HPLC, UV/Vis, Balances, Densitometer, Autotitrator, pH meter, Conductivity Meter, Total Organic Carbon Analyzer (TOC), Osmometer, Viscometer, Karl Fischer, Particle Counter, Malvern, Polarimeter, Microscope... (trained on NLT 11 laboratory instruments)
Perform pH adjustments
Perform Viscosity Ostwald viscosity
Perform Batch release testing
Autotitrator:
All products and titrant standardizations
Wet Chemistry testing of in-process bulk material, finished product,
Ex) TLC, Deliverable Volume, Opalescence, Degree of Coloration
Prepare and generate reports to support Critical System Release
Other duties as assigned.

Project/Other:

Maintain analytical trending and metric tracking
Trains other analysts in routine testing, as necessary
Supports laboratory investigations and/or studies, as necessary
Global Track Wise workflow for Deviations or Laboratory Investigations or Change Control
Proficient in one of the three:

Deviation or OOS/OOTr or Change Control
Must be able to complete LIR’s
Other duties as assigned

III.

Position Requirements :

Education or Equivalent:

Bachelor of Science in Chemistry or Sciences or equivalent work experience

Experience:

Experience in a lab setting (academic, intern or other)

Knowledge/Skills Requirements:

Demonstrated intermediate mathematical ability.
High level of attention to detail, well organized and multi-task oriented.
Strong communication skills both written and oral.
Strong problem solving and analytical skills.
Works well in a team environment with a variety of individuals and personalities within and between departments.
Review reports, etc. for accuracy and logic.
Must be able to multitask, be proactive and willing to take initiative and responsibility.
Should be familiar with cGMP and safe work practices.
Be organized. Maintain good records and be able to access them rapidly. Understand where information can be found.
Make sound judgments. Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically.
Demonstrated ability to read, write, and speak clear English.

Physical Requirements:

Ability to stand for up to 8 hours per day
Visual Acuity (20/30 corrected vision).
Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, writing, talking,…