Website Aequor Technologies LLC
Aequor Technologies LLC
Company : Aequor Technologies LLC
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
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.
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