Sr. QC Associate, QC Lab General

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 processe 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’ experience 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

Pay Rate Range: 30-34/hr depending on experience