Senior QC Associate

Fremont, CA, US • Posted 1 day ago • Updated 16 hours ago

Contract W2

Contract Corp To Corp

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Depends on Experience

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Job Details

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5S
Analytical Chemistry
Analytical Skill
Assays
Attention To Detail
Business Intelligence
Cell Culture
Collaboration

Summary

We are looking for Senior QC Associate for our client in Fremont, CA

Job Title: Senior QC Associate

Job Location: Fremont, CA

Job Type: Contract

Job Description:

Pay Range: $30hr - $35hr

Duties:

Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification, and Packaging testing.
Executes and coordinates analytical testing of bulk drug substance and drug product in a multi-product facility.
Execute and coordinate Raw Material sampling and testing, and sampling of clean rooms (as applicable).
Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation, and trending as needed.
Coordinates and maintains routine activities.
Responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs).
Performs duties under limited supervision and according to standard operating and QC procedures.
Trains other associates and technicians on methods and processes.
Work performed in a highly regulated (FDA, EMEA, MHRA, PMDA, etc.) environment.
Follow all applicable BI and BI Fremont SOPs, OCPs, and BGSs for cGMP, EHS, and Compliance.
Required to work according to given schedules and flexibility to adapt working schedule upon prior given notice.
Strong focus on execution of non-routine analytical methods or processes.
Performs testing and review within several different analytical technologies.
Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
Reviews and trends analytical data and compliance processes to identify out-of-trends.
Authors routine compliance documents.
Identifies process anomalies and areas for improvement for operations.
Manufacturing Cell Culture, Manufacturing Purification, Engineering & Technology, Quality Assurance, Quality Control, Quality Systems, Analytical Science

Skills:

Executes independently with adequate training 3-5 analytical testing methods with different analytical principles under minimum oversight by qualified staff.
Manages and reviews fundamental tasks such as but not limited to buffer prep, TCU maintenance, and cleaning.
Identifies and implements fundamental improvements to lab processes compliance activities. Responsible for routine quality and compliance activities (authoring of test methods, forms, SOPs).
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 appropriately. Maintains and improves lab areas according to predefined standards (5s).
Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
Conducts group trainings on compliance topics and scientific principles as needed.

Requirements:

Strong technical knowledge in analytical methods.
Work independently with very little supervision, champions problem resolution, knows when to escalate to line management, and provides compliant and smart solutions for moderately complex method and testing issues.
Coordinates work within the team and cross-functionally.
Reviews data and identifies discrepancies and ensures they are properly investigated, assessed, and appropriate root causes are put in place.
Represents team in matrix team meetings with cross-functional team members to resolve issues and produce solutions.
Trains other associates and technicians on methods and compliance.
This role provides necessary planning, interpretation, determination of acceptability of data to the FDA, EMA, and/or clients.
This role has high impact on site performance in terms of compliance.
Previous QC Experience preferred.
Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing.
Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the First-Time.
Proven experience with technical review, analysis, and interpretation of scientific data.
Strong written and verbal communication skills.
Experience with computer-based systems and experience with process control systems.
Previous experience to read and understand SOPs and/or methods and document work in a written format applying cGMP/GDP standards.
Ability to work as part of a high-performing team and collaborate effectively with staff.

Education:

High School Diploma with 6 years of experience in cGMP regulated industry or equivalent.
Associate Degree with 4 years of experience in cGMP regulated industry or equivalent.
Bachelor s Degree in a science or engineering-related field with 2 or more years of experience in cGMP regulated industry or equivalent.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10516350
Position Id: CA_SQAT_0121
Posted 1 day ago

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Senior QC Associate

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