The Quality Assurance Engineer role is responsible for supporting the Quality organization by providing Quality Support on the Production Floor, conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.
Essential Functions
Quality support on the manufacturing floor
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.).
Lead investigator for Out of Specifications results
Identify and implement Corrective Actions
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 SOPs
Maintain current knowledge of federal and international regulations regarding Microbiology, Chemistry and cGMPs
Provide support for FDA or other regulatory agencies for on-site audits
Requirements
Bachelor of Science in Biology, Chemistry, or a related field required
3 or more years of relevant experience required
Experience investigating exceptions and out-of-specifications preferred
Must be able to resolve problems, handle conflict, and make effective decisions under pressure
Root Cause Analysis
Action-oriented/drives for results
Ability to do simple to complex math calculations, input data into the computer, and analyze data as required
Ability to multitask projects
Must be proficient in the 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 communication skills
Ability to work independently and with others to accomplish goals and priorities
High level of energy and regular, consistent attendance
Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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 Staffing Group 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.beaconhillstaffing.com .
