Quality Control Validation Scientist

Lancesoft

Newbury Park (Thousand Oaks), CA

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JOB DETAILS

SALARY

$58

LOCATION

Newbury Park (Thousand Oaks), CA

POSTED

30+ days ago

Title: Quality Control Validation Scientist

Summary: As a QC Analytical Scientist, you will support various Quality Control activities within the AQC department. Key responsibilities are to transfer and execute analytical methods, including raw materials, for use in a cGMP environment in Quality control, both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).

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.

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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