MCS Senior Associate Quality Assurance jobs in United States
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Planet Pharma ยท 1 day ago

MCS Senior Associate Quality Assurance

positionThousand Oaks, CA
timeFull-time
remoteOnsite
senioritySenior Level
money$25/hr - $35/hr

Planet Pharma is seeking a Senior Associate in Quality Assurance to provide real-time QA support at their USTO site. This role involves cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing events, requiring hands-on experience in a GMP environment.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Provide real-time, floor-based QA support at USTO site
Support Clinical/Commercial drug substance production
Require cleanroom oversight
Batch record review
Acting as a QA liaison during manufacturing and facility events
Provide support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff
Purposeful presence on the floor
Electronic batch record review
SOP revision & approval
Work order approval
Quality approval of minor deviations
Evaluation of compliance issues
Providing recommendations
Assuring progress of quality records to completion
Represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals
Work in a team matrix environment

Qualification

GMP operationsQuality SystemsDocumentation evaluationProject managementCritical thinkingOrganizational skillsEffective communicationTeam playerLeadership attributes

Required

Hands-on QA or manufacturing experience in a GMP environment (preferably within biotech)
Strong critical thinking skills prioritized over academic credentials
Willingness to work onsite and rotate between day and swing shifts every six months
Ability to provide real-time, floor-based QA support
Experience with cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing and facility events

Preferred

Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field
Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices
Ability to make Quality based decisions in order to ensure compliance
Experience managing projects through to completion & meeting timelines
Evaluating documentation and operations according to company procedures
Experience working with Quality Systems
Strong organizational skills and ability to manage multiple tasks at one time
Effective communication skills (both written and verbal)
Demonstrated ability to work as both a team player and independently
Display leadership attributes and drive improvement initiatives

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.
dateFounded in 2009
location
Northbrook, Illinois, USA
people-size1001-5000 employees
web-link
http://planet-pharma.com

H1B Sponsorship

Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase