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.
Position Title: QA Specialist 1
Location: Rockford, IL - Assembly Drive
Department: QC Laboratory
Shift: 1st
Reporting To: QA Supervisor
Responsible For (Staff): no
The primary function is the timely and efficient review ensuring accuracy, completeness, and compliance to in-house, customer, and regulatory requirements, including data integrity, are met following the testing of pharmaceutical starting materials, components, and finished products using techniques such as manual/automated titrations, UV, FTIR, LOD, Karl Fisher, Water activity and Pharmacopoeial testing i.e. LOD, RI, ID, Limit tests, Training of personnel in data review in area of expertise. Author OOS investigations, determination of root cause, and development and implementation of corrective and preventative actions. Author investigations into deviations from defined procedures. Review regulatory bodies for changes applicable to the laboratory and ensure that any changes are implemented. Maintain metrics concerning area of responsibility. There are no supervisory responsibilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
GENERAL RESPONSIBILITIES
Timely and efficient review ensuring a high level of accuracy with minimal personal error, completeness, and compliance to requirements to ensure that Quality Assurance standards and regulatory requirements are met including data integrity
Works efficiently to generation and documentation of raw data by ALCOA principles
Knowledge of ICH Guidelines which pertain to services trained to review
Knowledge of USP and EP general chapters which pertain to techniques trained to review
Training of personnel in the review in the area of expertise
Attendance at staff meetings/laboratory departmental communication hurdles.
On-time completion of assigned training in ComplianceWire
Participate in internal Health and Safety audits including developing actions and follow up
Participates in internal, customer, and regulatory audits
Maintains a high level of good housekeeping
Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence
Implementation and execution of continuous improvement activities
Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
SPECIFIC RESPONSIBILITIES
Issue notebooks, worksheets, and test forms by defined procedure
Review all analytical data for manual/automated titrations, UV, FTIR (ID tests), LOD, Karl Fisher, Water activity, Incoming component testing, Pharmacopoeial testing, Limit tests, and Water testing.
Review general stability data for dissolution, assay, and related compound testing
Review basic analytical and/or microbiological tests for release and/or stability for assigned clients
Drive on-time completion of data correction activities in conjunction with the area Supervisor
Time Product OOS investigations and determination of root cause
Write and investigate deviations from defined procedures
Develop and implementation of corrective and preventative actions
Maintains customer methodology and reviews/approves electronic document management software (EDMS)
Maintain metrics concerning area of responsibility
QUALIFICATIONS:
Required:
Bachelor's Degree in a related field and/or 1-5 years of related experience and/or training.
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several... 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.
