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Simtra BioPharma Solutions · 2 days ago
Quality Lab Associate III - Raw Materials Testing
Bloomington, IN
Contract
Onsite
Senior Level
10+ years exp
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Maximize your interview chancesPharmaceutical Manufacturing
Insider Connection @Simtra BioPharma Solutions
Responsibilities
Operates applicable laboratory equipment such as HPLC, UV, Karl Fischer, pH meter, density meter, etc.
Performs advances biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
Performs testing in accordance with applicable Standard Operating Procedures (SOP’s).
Performs testing on raw material lots, in-process products, and finished product batches as required on the associated documentation.
Maintains data integrity and ensures compliance with company SOP’s and worldwide regulatory agency requirements.
Initiates Laboratory Investigation Reports.
Uses the US, EU, and Japan pharmacopeias (USP, EP and JP).
Serves as a mentor and trainer of all QLA personnel.
Performs transfers of methodology from clients and R&D to the QC Chemistry department.
Performs reviewing of all testing performed in the QC Chemistry department.
Participates in internal audits as required.
Troubleshoot and resolve instrument issues.
Uses sophisticated laboratory instrumentation and computer systems to collect and record data.
Works on special projects that involve new methods and instrumentation, including validations studies and development work.
Perform research and development studies.
Participate in laboratory software ownership activities.
Participates in continuous improvement activities that increase efficiency, solve problems, generate cost savings, and improve quality,
Performs internal laboratory checklist and audits.
Perform general laboratory/personal area clean-up.
Qualification
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Required
Bachelor’s degree in physical science required with a minimum of 10 years pharmaceutical laboratory experience or a Master’s degree in a physical science with a minimum of 4 years pharmaceutical laboratory experience
Must have been in a QLAII role for at least 4 years to master that skill set
Accurate and thorough with attention to detail
Strong communication skills, verbal, non-verbal and written, are required
Computer proficiency in Microsoft software programs and the ability to learn and use enterprise software
Must be able to wear personal protective equipment
Must be able to qualify for 20/40 corrected vision
Company
Simtra BioPharma Solutions
As a premier, independently owned CDMO with over 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class cGMP sterile fill/finish, technical expertise, quality service, and a uniquely collaborative approach.
1,001-5,000 employees
Funding
Current Stage
Late StageLeadership Team
Andy D.
Talent Acquisition Partner
Bernadette Wendelken
Senior Director, Pharma Partner Business Development
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