Job ID :
US - Maryland - Frederick
Key Objectives of the role:
- Performs quality control tests; use bioassay, biochemistry and protein biology methods.
- Collects and analyzes data for final disposition using preapproved documentation as well as performing investigation and troubleshooting.
- Establishes and performs stability testing and generates reports.
- Leads continuous improvement projects.
- Performs other related duties as required and/or assigned.
Minimum Qualifications (must have):
- Bachelor's degree in Biology, Molecular Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline.
- 3 - 5 years of related experience working in a biological quality control laboratory environment.
- Experienced within a biological quality control laboratory environment.
- Experience in cell culture and aseptic technique.
- Perform independently Biological Assays.
- Experience in Proliferation and Cytotoxicity testing.
- Proficient in ELISA testing.
- Experience in Inhibition of Proliferation, Chemotaxis, and ALP.
- Experience with isolation of PBMCs and Spleenocytes.
- Highly organized with strong attention to details.
- Ability to perform independently & as part of a team.
- Ability to lead moderately complex projects.
- Ability to work in dynamic, fast paced team environment.
- Excellent communication/interpersonal and presentation skills.
- Experience writing & reviewing technical documentation.
- Collects and analyzes data for final disposition using preapproved documentation as well as troubleshoots assays.
- Experienced with EHS guidelines in a laboratory environment, maintain well documented laboratory protocols and notebooks.
- Performs and documents equipment maintenance.
Preferred Qualifications (nice to have):
- Minimum 2 years’ experience within the clinical/medical device/pharmaceutical/biotech industry.
- Experience in working in FDA regulated environment.
- Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
- Proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g. Trackwise), including software programs generating reports and statistics.
- Ability to create, use and interpret scientific tables, charts, and graphs.
- Excellent problem solving methodology, using industry accepted concepts and tools to solve problems in creative and effective way.
- Possesses a strong scientific and technical background, sufficient to establish credibility with team as well as the manufacturing.
- Experience performing DNAse/RNAse assays using various instruments.
- Initiates problem reporting (deviations, non-conformances, failures, corrective and preventive actions) via Trackwise and performs root cause investigation and analysis for OOS and complaints.