QA Associate IV
Company: LanceSoft
Location: Fremont
Posted on: April 16, 2024
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Job Description:
Description
This position is on-site, responsible for quality oversight of a
GMP manufacturing facility, including manufacturing processes,
controlled areas, critical utilities (e.g. WFI, Steam, Automation,
equipment, HVAC, etc.), and batch record review.
Incumbent provides technical expertise on GMP equipment and Quality
Assurance standards and processes to team members. Ensures
compliance to clinical and commercial products cGMP regulations
during manufacturing and facility operations.
Duties & Responsibilities
Collaborate in evaluation of identified issues, resolution and to
ensure compliance with all applicable regulations.
Identifies, classifies and reports deviations. Oversees execution
of remediation/CAPA activities required to continue production or
move a process to the next milestone. Works closely with cross
functional team members to determine root cause and potential
preventative/corrective actions. Ensures support for the timely
closure of investigations.
uthorized to suspend any operation when the situation warrants and
immediately notify Quality Management. Provides guidance and
control directives regarding remediation activities required to
continue production. Is required to escalate critical issues within
area assigned to senior management team based on severity of the
issue.
Performs independent technical review of documentation during and
post-execution of cGMP activities, including batch records and Work
Orders. Ensures all specifications are met and that applicable
requirements are completed and acceptable. Ensures all
issues/documentation associated with each process in assigned area
have been resolved prior to release to the next step and are
compliant with cGMPs and SOPs and current manufacturing regulations
and site procedures.
Provides continuous improvement ideas in the assigned area tand
drive change through the use of Quality Systems. May attend project
team meetings to provide QA guidance and oversight to such
improvements.
Works closely with others in the assigned area to recognize
opportunities for improvement and drive change through the use of
BIFIs Quality Systems.
Requirements
Requires a Bachelors Degree preferably in sciences plus minimum of
3 years of experience working in the Quality related aspects of a
life sciences or closely related industry.
In lieu of a Bachelor's Degree, a High School Diploma plus 7 years
of experience working in the Quality related aspects of a life
sciences or closely related industry will be considered.
Related work experience executing on or overseeing equipment in a
cGMP environment.
Must be able to demonstrate understanding of biopharmaceutical
manufacturing, technical equipment, facility, Quality
Assurance/Systems and the interface between equipment and the
associated automation.
Has a technical understanding of manufacturing equipment
performance and can identify areas of improvement.
Must possess excellent verbal and written communication skills;
good interpersonal skills.
Strong independent judgment and decision making abilities
required.
Demonstrated problem-detection and problem-resolution skills
required.
Strong conflict resolution and negotiation skills required.
bility to communicate in an open, customer-focused manner.
bility to influence in a team environment and collaborate with
peers.
bility to interpret and relate Quality standards for implementation
and review to functional areas.
bility to work effectively on problems of diverse scope, with
analysis/evaluation of data.
ttention to detail, safety, quality and customer requirements.
Keywords: LanceSoft, Pleasanton , QA Associate IV, Other , Fremont, California
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