USA - Quality Compliance Specialist

The Fountain Group LLC

Newbury Park (Thousand Oaks), CA

JOB DETAILS
SALARY
$44.97–$46.52 Per Hour
SKILLS
Analysis Skills, Analytical Development, Analytical Method Validation, Biology, Biotech and Pharmaceutical, Chemistry, Code of Federal Regulations, Commissioning, Computer Systems, Current Good Manufacturing Practice (cGMP), Data Analysis, ICH Regulations, Identify Issues, Laboratory, Laboratory Equipment, Laboratory Operations, Maintain Compliance, Manufacturing, Materials Analysis, Microbiology, Microsoft Office, Pharmacy, Process Validation, Quality Control, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Statistics, Supervisory Control and Data Acquisition (SCADA), System Validation, Technical Writing, Validation Plan
LOCATION
Newbury Park (Thousand Oaks), CA
POSTED
4 days ago

The Fountain Group is currently seeking a Quality Compliance Specialist  for a prominent client of ours. This position is located in Newbury Park ,CA  .  Details for the position are as follows:

Job Title: Quality Control Validation Scientist
Location: Onsite (Mon–Fri, Flexible: 8:00 AM–5:00 PM or 9:00 AM–6:00 PM)
Pay Rate: $44.97–$46.52/hr
Duration: 6 Months

Job Description

The Quality Control Validation Scientist will support Quality Control Analytical (AQC) activities in a cGMP environment by transferring, validating, and executing analytical methods for raw materials and finished products. Responsibilities include analytical method validation/transfer, protocol and report generation, raw material qualification, laboratory equipment qualification, troubleshooting analytical methods, and supporting lifecycle validation activities while ensuring compliance with regulatory requirements.

Education

  • Bachelor's degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or related scientific discipline
  • Minimum 1 year of analytical development or validation experience in a pharmaceutical, biopharmaceutical, or related manufacturing environment (or an advanced degree)

Required Skills

  • Analytical method validation and method transfer
  • cGMP laboratory operations
  • Technical writing for validation protocols and reports
  • Analytical method troubleshooting
  • Raw material qualification
  • Laboratory equipment qualification (IQ/OQ)
  • QC analytical laboratory experience
  • Regulatory knowledge: cGMP, QSR, USP, 21 CFR, ICH
  • Statistical analysis for analytical data
  • Microsoft Office

Preferred Skills

  • Kneat validation software
  • Paperless validation systems for life sciences
  • Commissioning, Installation, Operational, and Performance Qualification (CQV/IQ/OQ/PQ)
  • Computer System Validation (CSV)
  • SCADA validation
  • MES validation
  • QC/Microbiology laboratory instrument qualification
  • Biopharmaceutical manufacturing environment
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About the Company

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The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/