The Senior Quality Control Testing Engineer role is responsible for supporting the Quality Control organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.
Essential Functions
Support or serve as lead 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.
Requirements
Bachelor of Science in Biology, Chemistry, or related field required.
Five 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, and conduct Root Cause Analysis.
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.
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 .
