Analyst, Quality Control
This positon requires a variety of skills necessary for biotech company operations. Independently perform routine and complex testing of process samples, raw materials, finished products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. Analyze and interpret results in written and oral format. Additionally, this position will support Preventative Maintenance and basic Laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review, training and mentorship of junior staff and contributions to process improvement initiatives.
II. Specific Duties, Activities, and Responsibilities:
- Accurately performs analytical and/or microbiological testing following SOPs
- Assists in developing and qualifying analytical and/or microbiological methods without supervision
- Reviews and verifies analytical and/or microbiological data and reports ensuring accuracy and consistency
- Accurately ships samples to clients and fills out appropriate paperwork
- Performs general lab housekeeping, including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, autoclaving, ordering and stocking supplies, etc.
- Accurately completes routine and preventative maintenance on laboratory equipment
- Actively participates in team meetings
- Authors technical documents such as Standard Operation Procedures, Certificates of Analysis, study protocols and reports.
- Trains junior staff on analytical and/or microbiological techniques and provides support in troubleshooting.
- Identifies and makes recommendations on efficiency and/or business opportunities within the group.
- Other duties as assigned
III. Position Requirements:
- PhD in Biotechnology, or related field, with no prior experience; or
- M.S./M.A. in Biotechnology, or related field, with minimum of 4 years’ experience in related laboratory work; or
- B.S./B.A. in Biotechnology, or related field, with minimum of 7 years’ experience in related laboratory work.
- Experience operating, maintaining, and troubleshooting sequencing techniques
- Aseptic technique experience
- Mammalian cell culture experience is preferred
- Preferred – HPLC, SDS-PAGE, Western Blot, HPLC, cIEF and ELISA experience, and/or Microbiology testing
- cGMP documentation practices
- Experience writing standard operating procedures
- General laboratory equipment experience, including micropipettes
IV. Dimensions of Position:
Scope of Responsibility:
- Direct Reports: N/A
- Total Site Staff (includes directs): N/A