Sr. QC Associate

Duties:

• 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.

• 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.

Skills:

• 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 escalate to line management.

• 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.

Education:

• 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.

Schedule Notes:1st Shift: Mon-Fri, 8AM-5PM

MAX BILL = ***/HOUR