Sr. QC Associate

Sigma Systems, Inc.; Fremont (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

Sigma Inc is seeking a Sr. QC Associate to join our Fremont, CA site. The 1st shift runs Monday–Friday, 8:00 AM–5:00 PM.

You will contribute to QC across HPLC/CE, potency testing, residual impurities, and microbiology, handling bulk drug substances and drug products in a multi-product facility. Responsibilities include authoring test methods, specs, plans, reports, SOPs, and training other associates while maintaining compliance with cGMP and GDP standards.

Qualifications

• Six+ years of experience in a cGMP regulated environment with a High School Diploma.
• Four years of experience in a cGMP regulated environment with an Associate Degree.
• Two+ years of experience in a cGMP regulated industry with a Bachelor's degree in a science or engineering field.

Responsibilities

• Executes independently 3–5 analytical testing methods under supervision.
• Manages buffer preparation, TCU maintenance, and cleaning.
• Documents work according to cGMP and GDP standards.

Skills

Attention to detail

Data analysis

Written and verbal communication

Education

High School Diploma

Associate Degree

Bachelor’s Degree in science or engineering

Job description

37757692 Sr. QC Associate Fremont, CA 12 Months
Sigma Inc is currently looking for a QC Associate to work in with our client in Fremont, CA
1st Shift: Mon- Fri 8.00 AM - 5.00 PM

• The SR QC Associate is 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.
• This role executes and coordinates analytical testing of bulk drug substances and drug products in a multi-product facility as well as executes and coordinates Raw Material sampling and testing and sampling of clean rooms (as applicable).
• The SR QC Associate coordinates routine-maintained activities and is responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs).
• This role performs duties under limited supervision and according to standard operating and QC procedures.
• Trains other associates and technicians on methods and processes.

Responsibilities:

• Executes independently, with adequate training, three to five (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.
• Conduct group training on compliance topics and scientific principles as needed.
• Performs testing and review within several different analytical technologies.
• 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.
• Provides compliant and smart solutions for moderately complex methods 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.

Requirements:

• High School Diploma with six (6) years of experience in cGMP regulated industry or equivalent.
• OR, Associate Degree with four (4) years of experience in cGMP regulated industry or equivalent.
• OR, Bachelor's Degree in a science or engineering related field with two (2) or more years of experience in cGMP regulated industry or equivalent.
• 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 mindset.
• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
• Proven experience with technical review, analysis, and interpretation of scientific data.
• Strong written and verbal communication skills.
• Experience with computer-based systems and ideally experience with process control systems
• Previous experience reading and understanding 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.
• Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed.
• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
• Strong focus on execution of non-routine analytical methods or processes.
• Strong technical knowledge in analytical methods.
• Ability to work independently with very little supervision.
• Champions problem resolution.
• Knows when to escalatest to line management.
• Strong technical knowledge in analytical methods.
• Work independently with very little supervision, champions problem resolution, knows when to escalatest to line management, and provides compliant and smart solutions for moderately complex method and testing issues.