Chemist II

Woodstock Sterile Solutions•Woodstock, IL

1d•Onsite

About The Position

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 Monday - Friday; 8 am - 4:30 pm. I. Position Overview: The position is responsible for testing and scheduling raw material samples, coordination with Incoming Quality Assurance and Supply Chain. Investigates out of specification test results. Provides support for New Product Introduction. II. Specific Duties, Activities, and Responsibilities: In addition to the Raw Materials Chemist I, Specific Duties, Activities, and Responsibilities the following duties and responsibilities are required: Robust understanding of regulatory and compendium requirements Able to compose robust investigations Assist in Manufacturing investigation, as necessary Trained on and competent to execute MasterControl Workflows (Deviation, Laboratory Investigation and Change Control) Able to sponsor change controls for SOP/RMS updates and equipment qualification. Demonstrates analytical problem-solving skills including troubleshooting laboratory and instrumental problems with little supervision. Demonstrates initiative and high level of thinking to resolve problems Detail oriented to perform peer review of results, investigations and protocols. Assist with regulatory and customer audits Assist with and conduct studies as requested by the Lab Supervisor/Manager Work independently and make quality decisions based on SOP requirements with minimal supervision. 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: Assist in Chemical Raw Material Specification (RMS) development and assess in house and contract laboratory testing capabilities. Instrumentation Identification of Raw Materials (HPLC/FTIR etc.). Instrumentation Chemical Assays of Raw Materials (Potentiometric and Redox Titrations/UV/HPLC/GC etc.). Schedule, review and approve annual qualifications, and repairs. Performs complex assays 1. Reflux and distillation titrations, as necessary. Project/Other: Maintain analytical trending and metric tracking. Trains other analysts in routine testing, as necessary. Prepare and execute laboratory studies/protocols to support instrument qualifications and method validation and/or verifications (in support of Compliance, Continuous Improvement and or New Product Development activities etc.). Trained on and competent to execute MasterControl Workflows (Deviation, Laboratory and Change Control). Author, lead and investigate deviant occurrences and propose effective corrective actions and CAPAs. Author, and investigate OOS/OOTr and propose effective corrective actions and CAPAs. Create/Update/Review laboratory test reports/procedures. Supporting instrument qualification, method transfers, protocol executions. Creating, reviewing, revising and in addition to following/executing the Standard Operating Procedures, Investigations, Protocols, Acceptance Methods and Test Data (Summary Results). Demonstrates analytical problem-solving skills including troubleshooting laboratory and instrumental problems with little supervision. Demonstrates initiative and high level of thinking to resolve problems. Communication with Customers and professional organizations. Other duties as assigned. III. Position Requirements:

Requirements

Bachelor of Science in Chemistry or Sciences or equivalent work experience
Minimum 18 months in Chemist Level 1 role or 3 years of external cGMP laboratory experience with evidence of leading investigations and strong technical writing skills with appropriate demonstration of Level 1 skills
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
Bring experience to the organization
Learn new skills; collect new information
Demonstrate willingness to share skills and information with others
Demonstrate a bias toward action
Get things done
Be willing to take a position and assert influence to drive improvement
Foster teamwork to get results
Meet deadlines and work under pressure with limited supervision
Perform independent work related to projects and/or routine activities
Must possess appropriate communication skills allowing direct interaction with WSS internal Managers and Sr. Management
Works well under pressure and able to prioritize workloads with little or no supervision
Maintain good records and be able to access them rapidly
Understand where information can be found
Demonstrated ability to read, write, and speak clear English
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

Responsibilities

Testing and scheduling raw material samples
Coordination with Incoming Quality Assurance and Supply Chain
Investigates out of specification test results
Provides support for New Product Introduction
Compose robust investigations
Assist in Manufacturing investigation, as necessary
Trained on and competent to execute MasterControl Workflows (Deviation, Laboratory Investigation and Change Control)
Able to sponsor change controls for SOP/RMS updates and equipment qualification
Troubleshooting laboratory and instrumental problems with little supervision
Perform peer review of results, investigations and protocols
Assist with regulatory and customer audits
Assist with and conduct studies as requested by the Lab Supervisor/Manager
Work independently and make quality decisions based on SOP requirements with minimal supervision
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
Assist in Chemical Raw Material Specification (RMS) development and assess in house and contract laboratory testing capabilities
Instrumentation Identification of Raw Materials (HPLC/FTIR etc.)
Instrumentation Chemical Assays of Raw Materials (Potentiometric and Redox Titrations/UV/HPLC/GC etc.)
Schedule, review and approve annual qualifications, and repairs
Performs complex assays
Reflux and distillation titrations, as necessary
Maintain analytical trending and metric tracking
Trains other analysts in routine testing, as necessary
Prepare and execute laboratory studies/protocols to support instrument qualifications and method validation and/or verifications (in support of Compliance, Continuous Improvement and or New Product Development activities etc.)
Author, lead and investigate deviant occurrences and propose effective corrective actions and CAPAs
Author, and investigate OOS/OOTr and propose effective corrective actions and CAPAs
Create/Update/Review laboratory test reports/procedures
Supporting instrument qualification, method transfers, protocol executions
Creating, reviewing, revising and in addition to following/executing the Standard Operating Procedures, Investigations, Protocols, Acceptance Methods and Test Data (Summary Results)
Communication with Customers and professional organizations
Other duties as assigned