Analyst, QC
Company
BioMarin Pharmaceutical Inc.
Location
North Bay
Type
Full Time
Job Description
Description
Who We Are
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
SUMMARY
The QC Analyst is an entry level role and is responsible for providing support to the on-time release, stability and non-routine testing of the pharmaceutical drug substances and drug product in a cGMP environment. The QC Analyst is responsible for providing support to activities related to sample and/or lab equipment management. The QC Analyst is responsible for supporting analytical method development, assisting with troubleshooting work and executing validation and transfer protocols, supporting the writing and reviewing of protocols and reports, supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods and when necessary providing support in the preparation of regulatory submission documents. This role may include overtime and shift work.
RESPONSIBILITIES• Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management. • Monitor lab equipment for Calibration needs, monitoring and tracking of issues related to instrumentation. • Support the scheduled testing by ensuring the required reagents and glassware are stocked appropriately.• Maintain the laboratory in an inspection-ready state• Perform Analytical testing incl: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, PCR, etc.• Testing of in-process samples, finished product, non-routine samples, packaging and stability, etc. in a cGMP environment.• Assist with preparation of protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies• Develop, optimize, validate and troubleshoot analytical test methods• Act as technical resource (SME) and train other analysts in areas of expertise• Evaluate results against defined acceptance criteria• Conduct and document laboratory investigations and deviations to completion• Support sample and record management for testing within the group and at CRO/CTO's• Manage shipment of materials and samples to other BioMarin sites, CRO/CTO's, or to in-country testing labs• Interact directly with regulatory agency inspectors during audits• Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary• Other duties as assigned
EXPERIENCE
Required Skills:
0 - 5 years professional experience with B.S. (or 0 - 2 years professional experience with M.S.)
Computer Literacy
Competent verbal and written skills
Desired Skills:• The optimal candidate will have both HPLC and cell-based assay experience.• cGMP Quality Control experience preferred.• Experience with platforms such as Empower, LabWare LIMS, SoftMax Pro, and Veeva preferred.• Experience with one or more of the following methodologies and technologies is a plus: qPCR, ELISAs, cell-based assays, HPLC, Ultra-High Pressure Liquid Chromatography, Gel Electrophoresis, and SDS-Page.
EDUCATION• BA/BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field • MS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 - 2 years professional experience).
EQUIPMENT
Basic laboratory equipment (for example: analytical balance, pH meter, pipettes, biosafety cabinets, fume hoods)
Experience with HPLC/UPLC, Cell Analyzers, Automated Pipettors (epMotion), Spectrophotometers, Thermocyclers for PCR is a plus.
CONTACTS
This role will interact with other analysts, leads, and supervisors within Quality Control on a regular basis.
SUPERVISOR RESPONSIBILITY
This role does not have direct reports.
SHIFT DETAILS
This role is on dayshift with a 4x10 schedule. Shift hours and days are as follows: Tuesday to Friday, 7:00 am to 6:00 pm.
ONSITE, REMOTE, OR FLEXIBLE
Onsite role.
TRAVEL REQUIRED
Travel not required for execution of day-to-day responsibilities. Travel may be required for special projects, trainings, or assignments on an as needed basis.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Date Posted
12/16/2023
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