Quality Engineer

Flexible & Integrated Technical Services

Job Location:

Alameda County, CA - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

For Validation services in the Quality area.

WHAT MAKES YOU A FIT:

The Technical Part:

Bachelors degree in Engineering and previous exposure in Validation Life Cycle activities within the Pharmaceutical or Medical Device industry.
Shift: Administrative & according to business needs
Bilingual: (Spanish and English)
Experience in:
- Quality: reviewing validation documentation procedures and change control.
- Sampling plans.

The Personality Part:

Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one your (many) talents. Being the Piece means youre full of bright ideas and eager to innovate always bringing top-quality results to the table. Are you ready to take on this new challenge

AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)

Knowledge of validation methodologies (IQ OQ PQ) and protocols.
Familiarity with Good Manufacturing Practices (GMP) Good Documentation Practices (GDP) and FDA/ISO regulatory requirements.
Proficient in using data analysis tools (Excel Minitab or equivalent).
Strong analytical and problem-solving skills. Excellent technical writing and documentation skills.
Willingness to work in cleanroom or controlled environments.
Knowledge of safety procedures and compliance with EHS regulations.
Ensure timely thorough and complete execution of all protocols meeting FDA requirements.
Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
Ensure documentation is thorough accurate and entered on a timely basis into the quality system.
Ensures complete and thorough investigation of all product failures batch failures and deviations associated with validation sampling and testing.
Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys puzzle: you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!

Are you the Next Piece

Required Experience:

Senior IC

For Validation services in the Quality area. WHAT MAKES YOU A FIT:The Technical Part:Bachelors degree in Engineering and previous exposure in Validation Life Cycle activities within the Pharmaceutical or Medical Device industry. Shift: Administrative & according to business needs Bilingual: (Spanish...

For Validation services in the Quality area.

WHAT MAKES YOU A FIT:

The Technical Part:

Bachelors degree in Engineering and previous exposure in Validation Life Cycle activities within the Pharmaceutical or Medical Device industry.
Shift: Administrative & according to business needs
Bilingual: (Spanish and English)
Experience in:
- Quality: reviewing validation documentation procedures and change control.
- Sampling plans.

The Personality Part:

Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one your (many) talents. Being the Piece means youre full of bright ideas and eager to innovate always bringing top-quality results to the table. Are you ready to take on this new challenge

AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)

Knowledge of validation methodologies (IQ OQ PQ) and protocols.
Familiarity with Good Manufacturing Practices (GMP) Good Documentation Practices (GDP) and FDA/ISO regulatory requirements.
Proficient in using data analysis tools (Excel Minitab or equivalent).
Strong analytical and problem-solving skills. Excellent technical writing and documentation skills.
Willingness to work in cleanroom or controlled environments.
Knowledge of safety procedures and compliance with EHS regulations.
Ensure timely thorough and complete execution of all protocols meeting FDA requirements.
Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
Ensure documentation is thorough accurate and entered on a timely basis into the quality system.
Ensures complete and thorough investigation of all product failures batch failures and deviations associated with validation sampling and testing.
Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements.