at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Primary function is to perform chemical and physical testing of pharmaceutical starting materials, components and finished products to client supplied and Pharmacopoeial methodology in accordance with regulatory standards with a high level of accuracy and minimal personal error.
The ability to successfully interpret and execute technically challenging methodology. Testing is performed using techniques such as FTIR, UV, Karl Fisher, HPLC, GC, TOC and Dissolution with calibration, maintenance and troubleshooting of this equipment.
Perform method development, validation and method transfers including authoring protocols and final reports. Training of analysts in techniques for which competency has been demonstrated. Authoring on-time investigations, OOS investigations and determination of root cause, including working with internal and external customers to resolve issues.
Development and implementation of corrective and preventative actions. Review and approval of technical data. Introduction of new equipment, including authoring and executing URS/IQ/OQ/PQ documentation. Write, review, and revise work practices, and test methods.
Project management. Generation of quotations for projects in area of technical expertise. Co-ordinate and schedule service engineers to ensure that equipment down time is kept to a minimal. Assist/lead customer audits. Maintain metrics with respect to area of responsibility.
Maintain and administer the stability database, including the set down and removal of samples at pre-determined timeframes. Drive on time completion of testing and data correction activities of all personnel performing testing in area of responsibility.
Allocation of testing to subordinates including collaboration with other department supervisors to ensure on time testing for other services. This role has supervisory responsibilities.
Essential Duties and Responsibilities:
Receipt and logging of samples into LIMS including setting up new product/test and specifications
Works in an efficient manner to a high level of accuracy with minimal personal error in: Manual/automated titrations, UV, FTIR, Karl Fisher, Water activity, Incoming component testing, Pharmacopoeial testing i.e. LOD, RI, ID, Limit tests, Water testing, HPLC, Dissolution, GC, TOC, Cleaning verification, Method transfer and Method development and validation.
Generation and documentation of raw data in accordance with ALCOA principles Ability to interpret different customer method requirements without supervision High level of competency in technically challenging methodology Knowledge of ICH Guidelines which pertain to services trained in
Knowledge of USP general chapters which pertain to techniques trained in Training of other analysts in techniques for which expertise has been demonstrated Participate in Product OOS investigations and assist in the determination of root cause Write calibration OOS investigations including RIT's and potential product impact assessments
Develop and implementation of corrective and preventative actions Write and investigate deviations from defined procedures
Work with internal and external customers to resolve issues associated with deviations and out of specification results.
On time investigations including raising extensions prior to the due date if required Attendance at huddles including leading on a rotating basis On time completion of assigned training in ComplianceWire
Participate in internal Health and Safety audits including developing actions and follow up Participates in internal and regulatory audits Participate in customer audits by assisting/leading the tour and answering questions
Prepares, discuss and present analytical data to internal and external customers and auditors Retains product on completion of testing and raw data upon issuance of analytical report/certificate of analysis
Maintains a high level of good housekeeping including ensuring that all glassware is disposed of and cleaned in a timely manner once analysis is complete and checked for compliance to specification
Maintains a high level of safety and highlights any... For full info follow application link.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
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