Job Description
GENERAL DESCRIPTION
The Research QC Associate has laboratory training in instrumental and analytical chemistry/bioanalytical techniques. This individual will work on a cross-functional team and be responsible for setting up and executing experiments, coordinating and prioritizing sample testing assignments, working efficiently, documenting results, performing peer data review, and communicating findings to the team in a GMP environment.
KEY DUTIES:
- Complete analyses as assigned and maintain laboratory notebook and records in accordance with GxP, cGMP’s and ALCOA+ principles.
- Execute analytical testing following compendia (USP, EP, JP), and in-house analytical procedures
- Write protocols and execute method verification/validation/qualification/ transfers
- Write, execute laboratory investigations as needed
- Drafting documents (SOPs, specifications, technical reports)
- Execute, oversee instrument qualification as necessary
- Document data as needed utilizing LIMS, ELN, SAP, SLIM and Oracle
- Troubleshooting of technical procedures, methodology and instrumentation
- Adhere to lab safety procedures and assist in maintaining a clean, safe workplace
- Order laboratory supplies
- Coordinate sending samples and receiving data from contract laboratories
- Be accountable to the team for ensuring proactive execution of work assignments
- Store, handle, and dispose of chemicals/reagents that they work with
- Operate and maintain laboratory equipment
- Assist with lab/product investigations and studies
TECHNICAL SKILLS:
- Chromatography (HPLC, UPLC, GC)
- ELISA
- Gel and capillary electrophoresis (SDS-PAGE, cIEF)
- UV absorption
- Particle size determination
- In-vitro analyses,
- Karl Fischer moisture
- Visual appearance
- pH
- Other modern analytical laboratory techniques
- Proficient in Microsoft Office
- Proficient in LIMS, Empower, Electronic Notebook (ELN) and lean laboratory operations
- Proficient in FDA, ICH, DEA, USP guidelines, cGMP regulations and laboratory safety procedures
- Proficient in laboratory instruments/qualification program as necessary
- Ability to react quickly to changes in project priorities and timelines.
PERSONAL ATTRIBUTES:
- Ability to cope with a rapidly changing work environment.
- Good interpersonal skills and ability to work effectively in a team environment.
- Commitment to continuous improvement in all areas.
- Ability to work safely; seek out and encourage safe practices
- The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills.
- Pays attention to detail and ensures high quality work
- Self-starter that takes initiative to perform work with minimal supervision
- Ability to meet timelines as assigned
- Willingness to learn new things
EDUCATION AND EXPERIENCE:
- Bachelor’s Degree in Chemistry/Biology or other relevant scientific fields of study with 1-3 years of industry experience.
Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.