Quality Associate I - 21622

Quality Associate I - Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below. Immediate opening for a Quality Associate I in San Diego, CA who possess:1-2 years of experience in a Pharmaceutical or Biologics Industry1-2 years of experience with Quality Assurance, Quality Inspection and testing experience preferred1-2 years of experience with Deviations, CAPAs, change controls, and strong documentation skills Email resumes to tness@simplybiotech.com and call 858.258.650. FULL DESCRIPTION: The selected candidate will be responsible for:Effectively communicate and collaborate with internal Quality Assurance, Manufacturing, Quality Control and Facilities teamsIssue and review executed production batch records and associated testing data to ensure the records meet cGMP expectationsParticipate in QA team meetingsSupports the use of and maintains Quality trackers as assignedAlign daily actions with department goals and company cultureDrive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priorityFosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality productControlled document review and /or batch release experience preferredAbility to open, investigate and effectively close Deviations, CAPAs and Change Control processesAbility to work independently, within prescribed guidelines, and as a team memberDemonstrated ability to work effectively in a dynamic, complex and fast-paced team environmentAbility to support a flexible work schedule to accommodate the Allermed Manufacturing scheduleWork in a team environment; including ability to organize, prioritize and promote teamworkDraft quality assurance policies and proceduresInterpret and implement quality assurance standardsEvaluate adequacy of quality assurance standardsDevise sampling procedures and directions for recording and reporting quality dataReview the implementation and efficiency of quality and inspection systemsPlan, conduct and monitor testing and inspection of materials and products to ensure finished product qualityConduct internal and external auditsDocument internal and external audits and other quality assurance activitiesInvestigate customer complaints and non-conformance issuesCollect and compile statistical quality dataAnalyze data to identify areas for improvement in the quality systemDevelop, recommend and monitor corrective and preventive actionsPrepare reports to communicate outcomes of quality activitiesIdentify training needs and organize training interventions to meet quality standardsCoordinate and support on-site audits conducted by external providersEvaluate audit findings and implement appropriate corrective actionsMonitor risk management activitiesAssure ongoing compliance with quality and industry regulatory requirements.The selected candidate will also possess:This position requires the following minimum education:High School EducationBachelor's degree (BNBS) preferredMinimum of 1-2 years of experience in Pharmaceutical or Biologics industry.Minimum of 1-2 years of experience in Quality Assurance and Quality Inspection and testing.Computer skills including Microsoft Office Word and Excel.Ability to comprehend math including ratios, multiplication, division, addition and subtraction.Position requires strong attention to detail, logical thinking, and an aptitude for multitasking. Salary Range: $31.25-33.65/hour.For immediate and confidential consideration, please email your resume to tness@simplybiotech.com and call 858.258.650. More information can be found at www.simplybiotech.com.Company DescriptionSimply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2022, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, TalentZok is expanding to new markets and hiring additional staff in existing offices.

Salary : $31 - $34