Job Information
PCI Pharma Services QA Specialist 2 in Rockford, Illinois
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 II
Location: Assembly Drive, Rockford, IL 61109
Department: QC Laboratory
Shift: First
Reporting To: QA Supervisor
Responsible For (Staff): None
The primary function is the timely and efficient advanced 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, HPLC, GC, TOC, Water activity and Pharmacopoeial testing i.e. LOD, RI, ID, Limit tests, Review of raw data generated for stability testing, release testing, cleaning verification, and method transfers. Training of personnel in data review in area of expertise, including mentoring and coaching. Author OOS investigations, determination of root cause, and development and implementation of corrective and preventative actions. Author investigations into deviations from defined procedures. Review of regulatory bodies for changes applicable to the laboratory and ensure that any changes are implemented. Maintain metrics concerning area of responsibility. Write, review, and revise work practices and test methods. Review and approval of stability protocols, Review and approval of method transfer protocols and reports. There are no supervisory responsibilities.
Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
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 efficiently met including data integrity Works 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 huddles. 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 extra hours and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
SPECIFIC 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 Issue notebooks, worksheets, and test forms by a defined procedure.
Timely and efficient review ensuring accuracy, completeness, and compliance to requirements to ensure that quality assurance standards and regulatory requirements are met including data integrity Basic review as needed for manual/automated titrations, UV, FTIR, LOD, Karl Fisher, Water activity, Incoming component testing, Pharmacopoeial testing i.e. LOD, RI, ID, Limit tests, Water testing, Stability data, Release data, cleaning verification data and Method transfer.
Advanced reviews for microbiological data, Stability Protocol, Method Transfer/Method Verification protocols for assigned Clients, advanced Stability data for assigned clients, and cleaning validations.
Drive on time completion of data correction activities in conjunction with the area Supervisor.
On time Product OOS investigations and determination of root cause.
On time Calibration OOS investigations including RIT's and potential product impact assessments.
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 entries.
Work with internal and external customers to resolve issues associated with deviations and out-of-specification results promptly.
Maintain metrics concerning area of responsibility.
Review and approval of customer-provided stability protocols.
Write/Revise WP's/Test Methods Mentoring/coaching.
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Required:
Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and know 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 abstract/concrete variables.
High Standard of Report Writing
NOTE: Employees who have received a counseling report for a violation occurring within the last 3 months are not eligible to apply for open positions.
Preferred:
Ability to demonstrate attention to detail.
Ability to adapt to a changing work environment.
Ability to hold oneself professionally.
Ability to identify and resolve problems promptly.
Ability to exhibit sound and accurate judgment.
Ability to demonstrate excellent time management skills.
Ability to display a willingness to make decisions.
Ability to take ownership of issues and work towards resolution.
Ability to work to ensure good interpersonal relations are
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled