Quality Control Scientist

Plastikon Healthcare is looking for a QC Scientist 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. The QC Scientist reports directly to the Quality Control Manager.

JOB ROLES REQUIRED FOR THE POSITION

• 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 as needed.
• 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.
• Other duties as assigned.

POSITION QUALIFICATIONS

Minimum Requirements:

• BS in science major or extensive equivalent experience,
• 3+ years in microbiology or 3+ years in chemistry with experience in a pharmaceutical or medical device facility.
• 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.
• Skills in HPLC analytical instrumentation preferred.

LANGUAGE SKILLS

Required reading, writing, and speaking fluently in English.

PHYSICAL DEMANDS

While performing the responsibilities of the job, the employee is required to talk and listen. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers to handle or feel. The employee is occasionally required to climb or balance, stoop, kneel, crouch, or crawl. Vision abilities required by the job include close vision. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.