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Senior Manager, Quality Assurance-217325
Cabazon, CA
Cabazon
CA
92230
Date
: Jul-07-21
2021-07-07
2022-07-07
Senior Manager, Quality Assurance-217325
Cabazon, CA
Jul-07-21
Work Authorization
US Citizen
GC
H1B
GC EAD, L2 EAD, H4 EAD, TN EAD
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect, Senior, Midlevel, Junior
Rate/Salary ($)
:
Market
Duration
:
Sp. Area
:
QA, Testing Automation
Sp. Skills
:
QA Mainframe Environment
Permanent Direct Hire
FULL_TIME
Direct Client Requirement
Required Skills
:
Business Intelligence, Word
Preferred Skills
:
Domain
:
IT/Software, Financial, Government, HealthCare, Retail, Dot Com, Insurance, Pharmaceuticals, Manufacturing, Telecom
Work Authorization
US Citizen
GC
GC EAD, L2 EAD, H4 EAD, TN EAD
H1B
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect, Senior, Midlevel, Junior
Rate/Salary ($)
:
Market
Duration
:
Sp. Area
:
QA, Testing Automation
Sp. Skills
:
QA Mainframe Environment
Permanent Direct Hire
FULL_TIME
Direct Client Requirement
Required Skills
:
Business Intelligence, Word
Preferred Skills
:
Domain
:
IT/Software, Financial, Government, HealthCare, Retail, Dot Com, Insurance, Pharmaceuticals, Manufacturing, Telecom
cyitechsearch
San Jose, CA
Post Resume to
View Contact Details &
Apply for Job
Job Description
:
Duties & Responsibilities:
Plans, directs and manages the work of the BI Fremont Quality Assurance group; establishes department mission statements; and provides technical leadership to ensure all necessary quality checks are completed on time, and according to SOPs.
Identifies deviations from SOPs in manufacturing operations; records and reports issues to appropriate parties; recommends corrective action and follows up to ensure resolved.
Provides oversight for the development of project budgets and monitors expenditures.
Optimizes allocated department resources.
Prepares for, manages and coordinates internal and customer audits including:
Coordination with internal contacts/customers on audit agenda
Completion of any internal/customer pre-audit requirements (questionnaires, etc.)
Coordination with internal departments on audit schedule
Coordination with internal departments and/or customer on responses to any observations
Overseeing tracking of CAPAs related to audits to monitor for timely completion
Requirements:
Requires a Bachelor's, Master's or PhD degree, from an accredited institution, preferably in Life Sciences Engineering or similar pursuit.
Requires a minimum of seven (7) years of experience working in the Quality aspects of a life sciences or closely related industry.
Requires a minimum of three (3) years of management and/or leadership experience, including experience managing within complex matrix organizations and projects.
Must have demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
Negotiating skills
Overall understanding of Quality Assurance specifications and process
Budgeting
Goal setting
In-depth understanding of Manufacturing/Pharma Business
Strong team leadership skills
Strong staff coaching and development skills
Strong ability to communicate in an open, customer-focused manner
Strong ability to influence in a team environment and collaborate with peers.
Strong understanding and appreciation for regulatory requirements and quality and compliance standards under which the Fremont site is operating
Strong team leadership skills
Strong ability to set vision and direction, set expectations and motivate
Strategic thinking and planning.
Performance focused, persistent, sound decision-making, open minded, innovative/creative and results oriented.
Ability to interpret and relate Quality standards for implementation and review to functional areas.
In-depth knowledge of relevant Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to quality testing.
Ability to work effectively on problems of diverse scope, with analysis/evaluation of data.
Ability to effectively communicate both verbally and in writing to peers, management and other functions; superior interpersonal effectiveness, facilitation and organizational skills.
High level of personal motivation and initiative, and ability to work independently on projects.
Ability to adapt and be flexible with project changes as well as a continuously-improving work environment.
Ability and willingness to maintain accurate and factual hard-copy and electronic records.
Ability and willingness to work, participate effectively in and lead a team environment, including cross-functional teams.
Attention to detail, safety, quality and customer requirements.
Proficiency with MS Office products (specifically Word, Outlook, and Excel)
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
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