Eurofins is the world leader in the food, bio/pharmaceutical product testing. It is also number one in the field of environmental laboratory services and one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services. With over $2billion in annual revenues and 25,000 employees across 250 sites in 39 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, biopharmaceutical, food, environmental, and consumer products industries and to governments. With over 25 years of experience in the crop protection industry, Eurofins Agroscience Services offers outstanding technical knowledge and project management skills. By acquiring a carefully selected range of CRO's, Eurofins Agroscience Services has created a unique portfolio of expertise that provides analytical, regulatory, and field support to plant breeders, agrochemical, biopesticide, biocide, and fine chemical manufacturers. Eurofins Agroscience Services is searching for a Quality Assurance Specialistto work in Easton, MD. Employee Responsibilities: Review protocols, procedures, data, reports, and other documents for internal accuracy, consistency and to ensure compliance with specified regulatory requirements, protocol, project plan, methods and SOPs. Prepares, issues, and tracks reports of observations noted during audits and inspections. Reviews and evaluates addressed deficiencies for clarity, completeness, correctness, and potential impact on compliance status. Works with staff to correct any noted deficiencies/inconsistencies. Works with staff, study directors, principal investigators, and management to detect and resolve any quality issues. Performs phase inspections of ongoing study activities. Ability to assess noncompliance situations and create an audit report. Files protocols, amendments, deviations, inspections, and other quality documents appropriately. Maintains computerized files to support audit activities. Maintains Master Schedule in accordance with specified regulations and standard operating procedures. Reviews equipment calibrations, qualifications, and validations for adherence to company procedures (e.g., SOPs) and federal regulations. Keeps supervisor informed of significant issues or developments identified during quality assurance activities. Assists with development, implementation, and monitoring of quality systems and procedures (e.g., CAPA, Metrics, Change Control, Training, etc.). Recognizes and supports opportunities for functional area improvement. Identifies compliance gaps in processes, systems and studies; influences and collaborates with employees and management. Assists with development of GLP and QA training materials. Assist with providing employee training. Perform facility audits to ensure departmental compliance with the regulations. May perform external GLP quality audits. Performs other related duties as required and directed. The Ideal Candidate would possess: Strong computer, scientific, and organizational skills Excellent communication (oral and written) and attention to detail Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Basic Minimum Qualifications: Bachelor's degree and three (3) years of quality assurance and five (5) years of GLP experience is required. A degree in a relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework is preferred. A Master's degree in a relevant field and two (2) years of quality assurance and GLP experience may be substituted for the bachelor's degree and experience. A PhD in a relevant field may be substituted for the bachelor's degree and experience. Authorization to work in the United States indefinitely without restriction or sponsorship What we offer: Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Position is full-time, Monday-Friday, 8 a.m.-5:00 p.m., with overtime as needed. Candidates currently living within a commutable distance of Easton, MD are encouraged to apply. Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Associated topics: process, quality assurance, quality assurance analyst, quality assurance engineer, quality assurance lead, software quality, software quality assurance, software quality engineer, test, tester