Hi,
Position: Sr. Quality Compliance Specialist
Location: Thousand Oaks, California (Onsite)
Duration: 12 + Months
Interview Mode: Video
VISA : , OPTGC
JD
MUST HAVE: LAB & GMP Experience
Drive analytical method validation/ transfer of laboratory methodologies
* Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
* Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements.
Essential Duties and Responsibilities:
Drive analytical method validation/ transfer of laboratory methodologies
Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols
Support troubleshooting of analytical methods
Ensure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
Responsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new products
Use sound scientific principles and statistical techniques to solve problems and make recommendations.
May Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
Responsible for deliverables to ensure timelines and milestones are met.
Other duties as assigned.
Qualifications
Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements
Knowledge of analytical methods and operations with strong emphasis in problem-solving.
Knowledge about analytical method validation.
Intermediate statistical knowledge and experience with data analysis
Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
Basic knowledge about regulatory requirements concerning analytical instrumentation, and test methods
Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.
Ability to complete tasks with minimal direction, demonstration of basic project management skills.
Ability to multi task in a highly dynamic and diverse environment.
Attention to detail, good organization, and time management skills to meet deadlines.
Proficient in Microsoft Office.
Strategically and business-oriented thinking
Education and/or experience
Bachelor's Degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
Minimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
Physical Demand
The overall physical exertion of this position requires light to medium work.
Working Environment
Normal office and laboratory environment.
May need to work in controlled or clean room environments requiring special gowning.
May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
Able to work more than 8 hours a day or 40 hours a work week as needed.
Additional Notes:
Nice to have the KNEAT Program, not required
** Experienced in reviewing and approving Life Cycle Validation Documents including:
Familiar with paperless validation software for life sciences
Commissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant.
Computer System Validation protocols and reports, including SCADA, MES.
QC/Micro Laboratory Instrument Qualification and method validation.
Niranjan Kumar | Technical Recruiter
Email:
Stellent IT | office :
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