Spectrum Biologics Inc. is a privately-owned biotechnology company committed to providing state of the art services for the discovery and development of novel bio-therapeutics. Spectrum Biologics Inc. is currently located at UGA’s Innovation Gateway in Athens, GA.
Job Opportunity: Quality Assurance Manager
Employment Type: Part-time
About Spectrum Biologics Inc:
Spectrum Biologics Inc. is a specialized contract research organization that support development and preclinical services. The company is currently located at UGA’s Innovation Gateway in Athens, GA.
We are currently applying to obtain CAP Certification for multiple assays and we are looking for a reliable Manager of Quality Assurance to ensure that all external and internal requirements are met.
The person in this position will be responsible for overall quality assurance activity of labs. The person should be familiar with GLP and CAP laboratory standards. Applicant should be able to manage quality assurance activity, handle documentation and records, check, monitor and control QA related activities, support the preparation of standard operating procedures, and conduct related trainings. Person should be able to review standard operating procedures, test procedures, and test reports. Person should efficiently review documentation and records for all laboratory activities such as installation, calibration, assay development, transfer, qualification/validation, and implementation of the assays in clinical trials studies in accordance with current GLP guidelines and industry standards for such assays. This position involves working on multiple projects concurrently in a fast-paced environment. This person must be able to work in a collaborative environment.
• A successful candidate will have demonstrated experience in the quality assurance activities of GLP lab.
• He/She should be interested and should have aptitude in learning ways of documentation and in record maintaining.
• Candidate must be flexible, pay attention to detail, and have excellent written and verbal communications skills.
• This person will work collaboratively with colleagues and have strong work ethics to meet demanding timelines.
• Candidate will be involved in obtaining and maintaining the appropriate certifications.
• Devise procedures to inspect and report quality issues
• Monitor all operations that affect quality
• Supervise and guide inspectors, technicians and other staff
• Assure the reliability and consistency of laboratory performance by checking processes and final output
• Appraise customers’ requirements and make sure they are satisfied
• Report all malfunctions to Laboratory Director to ensure immediate action
• Facilitate proactive solutions by collecting and analyzing quality data
• Review current standards and policies
• Keep records of quality reports, statistical reviews, and relevant documentation
• Communicate with external quality assurance officers during on-site inspections
Education and experience:
• B.Sc. or M.Sc. in Immunology/cell biology/molecular biology with 3-5 years of relevant industry experience in a related field is required.
• Experience with processes/guidelines related to GLP/GCP compliance procedures and a guideline is necessary.
• Great sense of responsibility and commitment
• Team player with strong communication skills
• Well-organized; well-developed time, task, and project management skills
• Goal oriented and strong critical and analytical thinking
• Attention to detail and always striving for high quality
• A dynamic, positive approach; pro-active; flexible; eager to learn
• Able to work independently and to manage multiple and varied tasks
• Very good knowledge of English (spoken and written)
• A full-time position, available immediately
• A challenging job in a dynamic and enthusiastic work environment
• Individual training and personal development opportunities
• A competitive compensation package
Contact: Jessica Hutcheson; email@example.com