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Job Description
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 abstract/concrete variables.
- High Standard of Report Writing
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 works toward resolution
- Ability to work to ensure good interpersonal relations are maintained
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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.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Top Skills
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
