Quality Control Analyst (Expert)

and those authorized to work in the U.S. can be considered as W2 candidates. Duration 07/26/2021 to 07/26/2022Location Berkeley, CA 94710Shift This is a night shift position. The training on day shift would last 4-6 weeks and then the rest of the time would be on grave shift.Night shift is 10:20pm-6:30amDEPARTMENT/TEAM DESCRIPTIONQC Potency- Perform activities associated with cGMP quality release and stability testing of rFVIII products, including reagent qualification, performing instrument calibration, performing hands on testing and review, archiving cGMP documents, and activities to maintain the laboratories in a compliant status.POSITION SUMMARYPerform cGMP testing and review of data and perform activities to maintain the laboratory in a state of compliance.POSITION DUTIES & RESPONSIBILITIESPerform testing and data review for release, stability, and reagent qualification:- Perform work according to cGMPs- Execute potency testing and review- Perform instrument maintenanceReport and review data in LIMS and SAP systems and routinely archive dataPerform routine compliance checks against weekly checklistREQUIREMENTS/PREFERENCESEducation Requirement(s):•Bachelor's Degree in Chemistry, Biochemistry, Engineering, or related field; 4+ years in a cGMP lab environmentSkill & Competency Requirements: •Able to work graveyard hours•Good written and verbal communication skills, basic mathematical skills•A technical background is required in areas such as analytical methods, instrumentation, computerized systems, biochemistry.•Experience within a cGMP and global regulatory compliance organization is required.•Adaptability to changing business requirements in a dynamic corporate environment is required.Preferences: •Experience with robotic platform (Hamilton) and/or Hematology instrumentation (such as ACL TOP 500)•A technical background is required in biochemistry, specifically in rFVIII Potency testing and data analysis of rFVIII product.•Knowledge on data integrity is required in areas such as following procedures / protocols, data recording rules, and data archiving.•Statistical analysis•Technical writing•Quality Control Experience•Location of this role site or remote? Location is on site.•What is a day like in this role? What 3-5 responsibilities will occupy their time?After initial training on day shift (4-6 weeks) the analyst would work on grave shift performing testing and reviewing of potency samples.Come onto shift in the laboratory, identify what testing is being performed for the day using a LIMS system for sample management, ensure reagents, instrument are ready for use, perform testing using analytical instruments including platform technology, and report results and review colleague's data. There is a huddle at start of shift and a PSS huddle at the end. Due to COVID there are safety precautions in effect, masks and social distancing.•Who will this person work with on a daily basis?There are limited people working grave shift on a whole. There is one manager and 2 analysts on the grave team, there are 11 (12 members with new employee) members currently on the day and grave team including managers.•Tell me about the team dynamic/culture.Team works together to complete critical testing. Analysts consult and coordinate with each other and the manager to complete daily tasks. There are team activities held virtually on day shift where grave members are invited to attend for team building activities.•What are the 'must haves' to be successful in this role?GMP experience, Analytical Chemistry/Biochemistry background (knowledge of analytical test methods and their function), Comfortable with using computers extensively •What is the long term plan for the role?This is a 6 month contract position, the position could be extended if justified, however, this is not intended to become FTE •What will make this opportunity stand out for potential candidates?Work with a reputable pharmaceutical company, opportunities to learn about large scale manufacturing in pharma industry, and application of scientific training towards analytical biochemistry: experience with ERP tools such as LIMS and SAP •Is this more maintenance or new development work?Maintenance•What kind of soft skills are you looking for?Excellent team player, communication, comfortable with honesty when errors are made, knowledge of limitations and knows when to consult for help, reliability and flexibility Benefits: