Chemist I (overnights)

Woodstock Sterile Solutions; Woodstock (IL); Sur place; USD 52 000 - 64 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits

Paid time off

Shift premium

Overnight schedule

Résumé du poste

Woodstock Sterile Solutions is seeking a Laboratory Analyst to test in-process and finished product samples, support investigations, and participate in process validation. You will prepare reports, maintain calibration and compliance, and help ensure product quality across sterile development projects.

The role requires a Bachelor of Science in Chemistry or related field, laboratory experience, strong analytical skills, and familiarity with cGMP.

Qualifications

• Bachelor of Science in Chemistry or Sciences or equivalent work experience.
• Experience in a lab setting (academic, intern or other).
• 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.

Responsabilités

• Completely, accurately and precisely prepares all laboratory reports and/or test scripts.
• Demonstrates high ethical standards and maintains training status on relevant equipment.
• Comply with all cGMP, regulatory and EHS requirements.
• Maintain laboratory in audit readiness per cGDP and cGMP practices.
• Perform analytical testing and calculations on in-process bulk material, finished product, cleaning and customer samples.
• Operate analytical instrumentation (HPLC, UV/Vis, etc.).
• Prepare and generate reports to support Critical System Release.

Connaissances

Mathematical ability

Attention to detail

Communication skills

Analytical skills

Teamwork

Multitasking

cGMP knowledge

Record keeping

English proficiency

Formation

B.S. in Chemistry or sciences

Outils

HPLC

UV/Vis

Balance

Densitometer

pH meter

TOC analyzer

Osmometer

Karl Fischer

Microscope

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Woodstock, IL, US

3 days ago Requisition ID: 1325

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 TrackWise 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, listening
• Occasional stooping, kneeling, crouching, bending, handling, carrying, grasping
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.