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:
Required Qualifications:
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.