Chemist I

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 Wednesday - Saturday, 7PM – 5:30AM, and is eligible for a 5% shift premium.

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.

Laboratory Skills:

• Perform analytical testing and calculations on in-process bulk material, finished product, cleaning and customer samples
• Receive and prepare reagents and standards
• Air dryer testing
• Perform Calibration Checks (Balance/pH/Conductivity/Pipettes etc.)
• 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:

1. Maintain analytical trending and metric tracking
2. Trains other analysts in routine testing, as necessary
3. Supports laboratory investigations and/or studies, as necessary
4. Global TrackWise workflow for Deviations or Laboratory Investigations or Change Control
5. Proficient in one of the three: Deviation or OOS/OOTr or Change Control
6. Must be able to complete LIR’s
7. 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.
• Excellent documentation skills.
• 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.