Quality Control Validation Scientist

USDM Life Sciences; Thousand Oaks (CA); On-site; USD 90,000 - 103,000; Full time

Job summary

USDM Life Sciences in Thousand Oaks, CA is seeking a QC Analytical Scientist to support analytical method validation, transfer, and execution in a cGMP environment within the AQC department.

You will generate technical documents, apply statistics, troubleshoot methods, maintain validated equipment, and ensure timely deliverables while adhering to regulatory standards such as CGMP, USP, ICH.

Qualifications

• Bachelor's degree in biotechnology, microbiology, pharmacy, chemistry or equivalent.
• At least 1 year of analytical development or validation experience in pharmaceutical/biopharmaceutical manufacturing.
• Experience with cGMP and regulatory requirements for analytical testing.

Responsibilities

• Drive analytical method validation and transfer of laboratory methodologies.
• Support execution and issue resolution of test plans/protocols.
• Support troubleshooting of analytical methods.
• Ensure laboratory equipment is maintained in a validated state and that transfers follow regulatory requirements.
• Prepare protocols, reports and other technical documents as required.
• Use statistical techniques to solve problems and make recommendations.
• Support IOQ, maintenance and troubleshooting of instrumentation in AQC.
• Ensure deliverables meet timelines and milestones.
• Other duties as assigned.

Skills

Technical writing

Analytical methods

Analytical method validation

Data analysis

Statistical techniques

cGMP knowledge

Regulatory requirements

Instrument/regulatory knowledge

Regulatory standards

Project management

Multi-tasking

Attention to detail

Microsoft Office

Strategic thinking

Education

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

Tools

SCADA

MES

Job description

Nature and Scope of Job

The QC Analytical Scientist 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).

Primary 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

Additional Qualifications

• 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.

Education & Certifications

• 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.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 65.00 - 75.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.