What are the responsibilities and job description for the Quality Assurance Specialist position at CTC?
ADDRESS - 8926 WARE COURT, SAN DIEGO, CA 92121 ONSITE POSITION - SHIFT - MON-FRI 8AM - 4:30PM - DURATION - 3 MONTHS - POSSIBLE TEMP TO HIRE IF VOLUME/SALES INCREASE.Position OverviewThe San Diego Clinical and Specialty Services (CSS) Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.Education and Experience:Bachelor’s degree required or equivalent relevant work experience.5-7 years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience.JD Edwards or comparable ERP systems preferred.Minimum of 3 years of customer service experience.Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.).Knowledge/Skills Requirements:Receives instruction, guidance and direction from othersUses existing procedures to solve routine problemsProactive to address work issues at the individual levelAbility to follow a variety of instructions furnished in written, oral, diagram, or schedule formMathematical and scientific reasoning abilityAbility to identify aberrant data and potential quality/compliance concerns escalating to managementAbility to work effectively under pressure to meet deadlinesSufficient skills and knowledge in the use of computers and associated computer technology (Microsoft Office Software = Outlook, Word, Excel, OneNote, PowerPoint)Computer technology relates to both the hardware and software used in performing common computing tasks. (JDE, TrackWise, Smartsheets).Proficient in Adobe AcrobatProficiency in all QS I itemsProficient in JDEAble to create Certificate of Analysis independentlyInspection of bulk drug and finished productAdhere to GMP standards routinely with limited errors and limited guidanceAble to help with investigationsAble to communicate to other teams about requirementsPerform effective rapid responseSubject Matter Expert in JDE related to MMQC processesCompany DescriptionAbout company - Since its founded in 1996, CTC has grown into a trusted global partner in AI & ML, Enterprise Applications, Digital Services, Managed Services, and Business Services. With headquarters in Detroit, Michigan, CTC has a team of over 2,000 experts worldwide. We empower more than 100 organizations to tackle complex challenges and transform them into sustainable competitive strengths--driving innovation, efficiency, and growth every step of the way. Our strengths have always been Commitment to Customer, Commitment to Colleagues, and Commitment to Community (CTC).
Salary : $43