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QC Lab Scientist/Chemist – Pharma Manufacturing
3 months ago
Our client – a growing company with multiple plants in the US, needs a QC Lab Scientist or Chemist at their plant expanding to manufacture pharmaceutical products. Excellent salary + Annual Bonus + Relocation + Full Benefit Package.
Job Posting # 2654
Job Title: QC Lab Scientist/Chemist – Pharma Manufacturing
Location: Lawrence, KS
Compensation: Salary range $70K- $85K
Relocation: YES - Client offers relocation assistance and payments for expenses
Benefits: Full package for medical, dental insurance, 401K + 3 Weeks’ Vacation + 13 days - PTO, etc.
Our client is a privately held company with manufacturing sites in CA + KS with around 300 people
Group Info: Be part of the medical device and pharmaceutical contract manufacturing site with around 120+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing.
The new operation expansion is for Pharma Fill Finish Seal – FFS of Sterile Aseptic liquids.
This Quality group has around 25 people from Quality Control, Quality Assurance, Compliance.
This role will report to the QC lab Manager.
This role could be for a Scientist or Lab Chemist person too or in between the 2 titles
Job Summary:
Responsible for developing and conducting laboratory testing to support cGMP sterile drug and aseptic medical device and pharmaceutical manufacturing operations.
The QC Scientist performs analytical tests by following SOPs and/or USP methods. Testing includes water testing, pH, conductivity, FT-IR identification, particulate monitoring, HPLC assays, and various USP wet-chemistry assays.
This position requires attention to detail, requiring a proactive individual who can assist in new assay development and product transfers.
The QC Scientist will be responsible for generating and revision laboratory procedures, performing audits, and reviewing data for compliance
Job Description:
Performs physical and chemical analysis of raw materials, in-process, and finished products by using analytical techniques such as FT-IR, HPLC, Conductimetry, TOC, and Refractive Index by following the SOPs.
Prepare samples for analysis involving thorough cleanliness and complex steps for aseptic techniques.
Creates and maintains laboratory record documentation, updates the master control, and prepares the COAs.
Actively participates in the investigation of Laboratory results, when required. Assists, as and when needed, scientists working in the laboratory.
Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.
Prepares volumetric test solutions following USP and/or in-house methods for wet chemical tests, standardizes such solutions as required, and standardizes API for use as in-house reference standard as assigned.
Performs this job role in support of laboratory equipment and assumes accountability for the work performed. Actively review reports and documents for compliance with requirements. Assists the Quality Manager in tracking calibration for the laboratory.
Uses the purchasing system to procure laboratory supplies.
Actively uses the Document Change System to generate or revise documents, as needed.
Supports the nonconformance system through reporting of Nonconformances and supporting Quality in investigation activities.
Provides reports and communication based on investigation findings.
Candidate Must Have:
BS in Chemistry or Microbiology or related degree
Min. 3 years of Chemistry or Microbiology QC experience in BioPharma or Med device Industry
Experience in cGMP, and Quality Systems
Wet chemistry, method development/verification/validation, calibration and lab equipment maintenance, variety of microbiological assays including sterility testing, microbial counts, microbial isolation and identification, environmental monitoring, and water testing.
Candidate Nice to Have:
Advanced degree
Experience with remediation of Quality systems in FDA 483, warning letter environment
Startup or Small company experience working in a dynamic and hands-on role.
Knowledge of Sterile Aseptic Filling Operations
Skills in HPLC analytical instrumentation preferred.
Contract Manufacturing experience working closely with customers and clients
Keywords: BioPharma, Pharma, Quality, QC, Scientist, Chemist, FDA, QA, CMO, Sterile Aseptic, filling, HPLC.
