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.

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.

The Quality Assurance Specialist II position is an integral member of the Quality Control Laboratory team supporting review and release of Laboratory testing. This colleague will ensure 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. Review of data includes the following microbial and analytical testing: Identification by FTIR/HPLC/UV-VIS, Assay Testing, Dissolution Testing, manual/automated titrations (Karl Fischer), Water Activity Testing (Rotronic Hygrolab) US and European Pharmacoepia Monograph/ID Testing/Limit Testing, Related Compounds Testing, Content Uniformity Ion Chormatography, Gas Chromatography, Cleaning Validation/Recovery Study, Gas Chromatography Mass Spectrophotometer Testing, and physical testing (Appearance, Friability and Disintegration) and classical wet chemistry testing (pH Testing, Conductivity Testing). This position will require training of other associates in review of data for which competency has been demonstrated. In addition, the Quality Assurance Associate II will author Out-Of-Specification Investigations and Deviations from defined procedures. This will require determination of root cause and development/implementation of corrective and preventative actions. The Quality Assurance Associate II is also responsible for review and approval of Laboratory Stability Protocols.

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
• 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

Required Qualifications:

• Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has 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

This is a second shift role working four 10 hour days, Monday to Thursday, 2PM to 12:30AM (or 12PM to 10:30PM)

Join us and be part of building the bridge between life changing therapies and patients.

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.

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Join us and be part of building the bridge between life changing therapies and patients.

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.