QA Associate II
Company: Cortech
Location: Fremont
Posted on: January 13, 2021
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Job Description:
DutiesResponsible for executing QA operations and overseeing
junior team members as they assess,evaluate, and review operations
on the floor (as defined above) against cGMPs to assure
realtimeobservation of activities, issue identification/ resolution
including proper and timelydocumentation. Provides guidance to MFG,
E&T, and/or QC to ensure compliance with allapplicable
regulations and assists in resolution of issues identified.
Information must be proactivelyshared across QA and the business
including the on-going training of junior teammembers.---
Identifies, classifies and reports deviations, as appropriate and
typically works on more complexMinor and/or Major deviations.
Oversees execution of remediation/CAPA activities required
tocontinue production or move a process to the next milestone.
Works closely with others todetermine root cause and potential
preventative/corrective actions. Ensures support for the
timelyclosure of investigations.--- Authorized to suspend any
operation when the situation warrants. Provides guidance and
controldirectives regarding remediation activities required to
continue production. Is required to resolvecritical issues within
area assigned and may escalate to senior management team based
onseverity of the issue.--- Responsible for providing quality
oversight to the change management system for complex Minorand/or
Major classified Change Controls. This includes providing plan
creation oversight,verifying that changes adhere to local SOPs and
regulatory compliance and ensuringcommunication/escalation of
potential issues of broader impact to the business.--- Performs
independent technical review of documentation during and
post-execution of cGMPactivities. Has authority to sign
off/qualify/train junior staff on QA Operation
responsibilities.Ensures all specifications are met and that
applicable requirements are completed andacceptable. Ensures all
issues/documentation associated with each process in assigned
areahave been resolved and approved prior to release to the next
step and are compliant with cGMPsand SOPs and current manufacturing
regulations and site procedures. Analyzes and reportsfindings to
appropriate departments.--- Works closely with others in the
assigned area to recognize opportunities for improvement anddrive
change through the use of BIFI's Quality Systems. May be asked to
become a certifiedGreen-Belt and be assigned to lead process
improvement initiatives via the BPE program. Mayalso attend, as a
QA project team member to provide QA guidance and oversight to
suchimprovements.--- Will serve as Subject Matter Expert for
internal or external matters. Participates in inspectionreadiness
activities and significantly involved in inspections by regulatory
agencies.--- Creates and establishes processes and procedures to
ensure compliance and adherence toregulated QA activities for cGMP
operations.SkillsStrong independent judgment and decision making
abilities required.--- Strong knowledge of relevant regulatory
guidances.--- Demonstrated problem-detection and problem-resolution
skills required.--- Strong conflict resolution and negotiation
skills required.--- Must possess demonstrated organizational skills
that have proven results in the ability to be selfdirectedwhile
managing multiple projects.--- Must possess excellent verbal and
written communication skills; good interpersonal skills.---
Capability to establish good relationships with others who have
different values, cultural stylesand perspectives.--- Setting high
and ambitious goals and standards for oneself and others,
continuously raises thebar.EducationRequires a Bachelor's Degree
from an accredited institution preferably in sciences plus
minimumof three (3) years of experience working in the Quality
related aspects of a life sciences or closelyrelated industry.---
In lieu of a Bachelor's Degree, a High School Diploma plus seven
(7) years of experience workingin the Quality related aspects of a
life sciences or closely related industry will be considered.
Keywords: Cortech, Fremont , QA Associate II, Other , Fremont, California
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