RFD_QA Specialist 2

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.

Summary of Objective:
Primary function is the timely and efficient advanced review ensuring accuracy, completeness and compliance to in–house, customer and regulatory requirement, 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 develop 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 ensuring that any changes are implemented. Maintain metrics with respect to 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.

• 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

• Record and maintain all related data and records in compliance with cGMP and ALCOA principles

• Knowledge of USP/EP general chapters and ICH guidelines which pertain to job function

• Train other associates in data review for which expertise/competency has been demonstrated

• 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 safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence

• Participates in implementation and execution of continuous improvement activities

• Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory

• Knowledge of and adhere to all PCI, cGMP, and GCP policies, procedures, rules

• Embodies cultural values and aligns daily actions with department goals and company culture

• This position may require overtime and/or weekend work

• Performs other duties as assigned by Laboratory Management

• Performs review of microbial testing and analytical chemistry testing related to QC functional responsibilities. Supports Commerical and Clinical stability and release by performing review of analytical testing of raw materials and drug products for the following tests in accordance with GMP, GLP and company test methods:

• Issue notebooks, worksheets and test forms in accordance with defined procedure

• Plans and organizes work with periodic supervision and communicates data review progress to Laboratory Management as needed

• Ability to interpret different customer method requirements with minimal supervision

• Actively participates in and method transfer and/or method validation activities between facilities within the organization or between organizations by reviewing method transfer protocols and reports for any of the above analytical testing listed

• Technical Data Review of New/Revised Test Methods/SOP’s/Work Practices

• Authors deviation investigations, Out of Specification investigations, Out of Trend investigations, develops Corrective Actions/Preventative Actions as needed.

• Reviews data using statistical tools such as Chromatography Data System (Chromeleon) and Microsoft Excel

• Gathers data for APR’s and authors APR reports for various customers

• Drives on time completion of data correction activities in conjunction with the QA Supervisor

• Associate should be self-motivated, organized, capable of working independently and in a collaborative environment

• Ability to prioritize and multi-task concurrent project demands, while maintaining exceptional attention to detail as well

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 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 in a professional manner.
• Ability to identify and resolve problems in a timely manner.
• Ability to exhibit sound and accurate judgment
• Ability to demonstrate excellent time management skills
• The 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 maintained

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.