Summary of Position
This role is responsible for supporting the Quality Systems organization through conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.
Essential Functions
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Support and serve as investigator for Out of Specifications results.
- Identify and implement Corrective Actions.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Support or serve as lead investigator for Exceptions to Standard Operating Procedures.
- Generate or review Change Controls for Standard Operating Procedures, Standard Test Methods, Data Sheets, etc.
- Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects.
- Perform statistical analysis of laboratory data in support of investigations, cost savings, continuous improvement initiatives.
- Generate, execute and manage protocols for Method Validations, Equipment Qualifications Work with radioactive materials.
- Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP's.
- Maintain current knowledge of US and international regulations regarding Microbiology, Chemistry and cGMP's.
Provide support for regulatory agency (i.e. FDA, HC, EU, TGA, etc.) on-site audits.
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Requirements
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Bachelor of Science degree in Life Sciences or Engineering required, or equivalent experience.
- Three or more years of relevant experience in a pharmaceutical/medical device manufacturing environment with strong understanding of and exposure to applicable quality systems required.
- Working knowledge of cGMP guidelines and their application in a controlled aseptic environment preferred.
- Must have awareness of quality systems including Change Control, Internal Auditing, Corrective Action Program, Deviation and Complaint investigations, and Document Management.
- Must have experience with statistical tools.
- Ability to do simple to complex math calculations, input data into the computer and analyze data as required.
- Must be proficient in use of Microsoft suite office products; Good computer skills, including utilizing personal computers and data entry programs.
- Good hands on, analytical, and problem solving and decision-making skills.
- Excellent writing and verbal communications skills.
- Ability to work independently and with others to accomplish goals and priorities.
- High level of energy and regular, consistent attendance.
Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.
California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
Company Profile:
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com.
Benefits Information:
Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.
We look forward to working with you!
Beacon Hill. Employing the Future™
