QC Associate II
Company: LanceSoft Inc
Location: Fremont
Posted on: January 23, 2023
Job Description:
Position: QC Associate II
Duration: 12 months
Location: Fremont, CA, 94555
Shift: 1st
Duties:
- Executes and coordinates data management in a multi-product
facility.
- Performs internal support duties including stocking
consumables/materials, updating controlled SOP binders, test record
issuance and reconciliation, filing, document archival, and
document compiling for lot release.
- Delivery of high-quality analytical results within timeline
right the first time Documents work according to cGMP and
cGDP.
- Adheres to established regulations and follows cGMP established
by site.
- Reports abnormalities and deviations in a timely and accurate
manner.
- Adheres to safety standards and identifies unsafe situations /
habits and escalates approriately.
- Maintains work production areas according to predefined
standards (5s).
- Maintains own training within compliance and trains other
technicians and associates on operations upon completion of trainer
qualification.
- Represents QC operations on cross-functional root cause
analysis teams for deviations, CAPAs and risk assessments
Skills:
- 3-5 years of industry experience depending on educational level
(see Education requirements) GMP experience is highly preferred
Demonstrates strong interpersonal and communication skills (both
written and oral), a strong customer focus, and an ability to
interact with various departments and levels.
- Demonstrates ability to work independently and as part of a
team, to meet departmental/facility goals; is also able to work
across functions to achieve common goals.
- Demonstrates strong attention to detail, and an ability to
focus on details of execution
Education:
- Bachelors Degree in a science or engineering related
field.
- In lieu of a Bachelor's Degree, experience in a regulated or
equivalent industry accepted in addition to those specified in the
required capabilities:
High School Degree with 4 years experience; or Associate Degree
with 2 years experience
Required:
" ROOT CAUSE ANALYSIS
" SAFETY STANDARDS
" FILING
" SOP
" RECONCILIATION
Additional:
" CGMP
" GMP
" OPERATIONS
" RISK ASSESSMENTS
" STOCKING
" DATA MANAGEMENT
Keywords: LanceSoft Inc, Fremont , QC Associate II, Other , Fremont, California
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