Ref No.: 18-03231
Location: Woodstock, Illinois
Start Date / End Date: 06/04/2018 to 09/03/2018
Description/Comment: The position is responsible for of raw materials, in-process, finished product and stability samples. Investigates out of specification test results. Provides lab support to process validation activities. II. Specific Duties, Activities, and Responsibilities: Perform analytical testing and calculations on raw materials, in-process bulk material, finished product, cleaning, customer and stability samples Operate analytical instrumentation such as HPLC, UV, FTIR. Prepare test reports and perform cGMP documentation in all areas of the laboratory. Perform peer review of documentation. Conduct investigations as necessary Maintain current training status on equipment and procedures. Maintain current record of raw material specifications and compendia guides. Calibrate, revalidate and maintain instruments and equipment in accordance with SOP requirements. Perform equipment and instrument validations/qualifications and method validations. Write and revise test methods and SOPs - Interface with regulatory agencies and customers. Assist with audits as needed. Assist with studies, prepare purchase orders, maintain inventory of standards, chemicals, reagents and supplies, prepare glassware and supplies for testing and other duties as assigned. Provide chemical testing support for NPD and Validation protocols. Review and approve documentation for the release of product. Provide testing support for Out of Specification (OOS) investigations and non-routine events. Investigate for the root cause of the OOS. Maintain trend analysis for Batch and First Acceptable samples. Maintain the laboratory per cGMPs. Complete tasks as required (in a timely manner), compliant with cGMP, regulatory and corporate requirements and conform to Health, Safety & Environmental responsibilities. Documents all work to cGMP and corporate standards with few errors. Creating, reviewing, and revising, in addition to following/executing the following document types: Standard Operating Procedures (i.e. Laboratory Procedures) Investigations Analytical Protocols Acceptance Methods Test Data (Summary Results) Supplies complete and organized data for report generation. Follows procedures as written and trains other analysts. Demonstrates multi-tasking ability and the ability to prioritize the work for multiple projects or materials on a daily and weekly basis. Coordinates and performs assigned projects as needed. Compares data to specifications, recognizes and reports to supervisor atypical data and demonstrates the ability to observe and communicate trends in data and develop/contribute to "continuous improvement” plans. Capable of recognizing data trends with supervisory guidance. Proficient in multiple laboratory techniques and is able to perform these techniques on a routine basis. Demonstrates analytical problem solving skills including troubleshooting laboratory and instrumental problems with little supervision. Demonstrates initiative and a high level of thinking to resolve problems. Follows and is able to recommend changes to all applicable SOPs and protocols. Communication with customers occurs under general supervision. In addition, communication with professional organizations may be required. May make formal presentations to small groups. Is capable of writing general technical reports and assisting in generating complex technical reports with specific guidance. Demonstrates high ethical standards. Maintain effectiveness of the Quality System. Other duties as assigned.
Location: 102 2210 Lakeshore Dr. Woodstock IL 60098 United States
Education:
Additional Job Details: Experienced Chemist. ten years of experience of Instrument validation including implementing and authoring Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) in a pharmaceutical environment. Commissioning and decommissioning experience of existing and new instrumentation. Ability to write user requirement specifications and procedures Experience in authoring in a change control system Shifts are... 1) 2nd shift 1-930, Sun, Mon, Tues, Wed, Thur. 2) 1st shift 8 am - 4:30pm, Tue, Wed, Thur, Fri, Sat. 3 Month assignment to start, can be extended for the right hire. Perform analytical testing and calculations on raw materials, in-process bulk material, finished product, cleaning, customer and stability samples Operate analytical instrumentation such as HPLC, UV, FTIR Prepare test reports and perform cGMP documentation in all areas of the laboratory Maintain current training status on equipment and procedures Maintain current record of raw material specifications and compendia guides Calibrate, revalidate and maintain instruments and equipment in accordance with SOP requirements Perform equipment and instrument validations/qualifications and method validations. Write and revise test methods and SOPs Interface with regulatory agencies and customers. Assist with audits as needed Assist with studies, prepare purchase orders, maintain inventory of standards, chemicals, reagents and supplies, prepare glassware and supplies for testing and other duties as assigned. Provide chemical testing support for NPD and Validation protocols Review and approve documentation for the release of product Provide testing support for Out of Specification (OOS) investigations and non-routine events. Investigate for the root cause of the OOS. Maintain trend analysis for Batch and First Acceptable samples. Maintain the laboratory per cGMPs. Complete tasks as required (in a timely manner), compliant with cGMP, regulatory and corporate requirements and conform to Health, Safety & Environmental responsibilities. Other duties as assigned. Minimum Requirements: Bachelor of Science in Chemistry 10 years experience Experience in a cGMP and/or pharmaceutical manufacturing environment desired Demonstrated intermediate mathematical ability. High level of attention to detail. Excellent documentation skills. MS Office (Word, Excel, Outlook, PowerPoint) Strong problem solving and analytical skills. Ability to work independently on multiple projects. Works well in a team environment. Possess and demonstrate excellent verbal, written and interpersonal communications skills. Well organized and high level of attention to detail. Works well under pressure and able to prioritize workloads with little or no supervision. Must be able to interact effectively with a variety of individuals and personalities within and between departments. Should be familiar with cGMP and safe work practices Demonstrated ability to read, write, and speak clear English
Job Qualifications Education or Equivalent:
Bachelor of Science in Chemistry or Sciences or equivalent

Experience:
0-5 years experience. Experience in a cGMP and/or pharmaceutical manufacturing environment desired

Knowledge/Skills Requirements:
Visual Acuity (20/30 corrected vision). Demonstrated intermediate mathematical ability. High level of attention to detail. Excellent documentation skills.
A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.). Strong problem solving and analytical skills. Must possess appropriate communication skills allowing direct interaction with outside suppliers, STW internal Managers and Sr. Management. Ability to work independently on multiple projects. Works well in a team environment.
Possess and demonstrate excellent verbal, written and interpersonal communications skills. Well organized and high level of attention to detail.
Works well under pressure and able to prioritize workloads with little or no supervision. Must be able to interact effectively with a variety of individuals and personalities within and between departments. Perform independent work related to projects and/or routine activities. Review reports, etc. for accuracy and logic.
Must be able to perform risk assessments in a timely manner and act accordingly.
Must be proactive and willing to take initiative and responsibility. Should be familiar with cGMP and safe work practices. 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.

Physical Requirements:
Ability to stand for up to 8 hours per day 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

Business Environment:
Fast-paced Performance driven Customer focused Collaborative and inclusive
Business Unit MDS - Medication Delivery Solutions
Sub-Business Unit Sterile