Quality Control Analyst - GMP Analytical & Molecular Testing

Direct Biologics is seeking a Quality Control Analyst to execute GMP analytical testing for release and stability, and maintain compliance with FDA and cGMP standards.

Requirements

• Strong knowledge of analytical techniques such as plate-based ELISA, immunostaining assays, quantitative PCR, and RNA and protein isolation and quantification methods.
• Strong technical understanding and working knowledge of contemporary molecular biology, cell biology, microbiology and/or biochemistry.
• Highly experienced with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) and authoring Quality Control protocols and reports.
• Excellent attention to detail and analytical skills, with the ability to interpret and present data effectively.
• Advanced data management encompassing various statistical analyses such as means, standard deviations, coefficients of variation (% standard deviation), and control charting.
• Strong organizational and time management abilities to meet deadlines in a fast-paced environment.
• Proficient in laboratory equipment and instrumentation operation and maintenance.
• Experienced in cGMP, OOS, deviations, and CAPA documentation with the capability to conduct root cause analysis.
• Ability to work independently as well as collaboratively in a team-oriented setting.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Company 401k match up to 4%
• Paid Time Off (Vacation & Sick)
• Holidays
• Stock Option