Technical Specialist

Job Overview
The Technical Writer/Compliance Specialist will be responsible for ensuring quality system compliance within the Technical Services (TS) department by managing quality documentation, leading investigations, coordinating corrective actions, and overseeing compliance with Environmental Health and Safety (EHS) and Good Manufacturing Practices (GMP).

Key Responsibilities

• Manage quality system tasks, including SOP creation/revisions, training records, and change control coordination.
• Facilitate root cause analyses for deviations, lead cross-functional investigations, and implement corrective actions using methodologies like DMAIC.
• Represent TS in site-level change control meetings and manage related documentation.

Qualifications and Skills
A Bachelor's degree in a technical field, such as Microbiology, Biology, Biochemistry, Chemistry, Engineering, or Pharmacy. Equivalent experience with sufficient technical depth will also be considered.

Experience

• Minimum of 3 years' experience in pharmaceutical manufacturing or quality assurance, focusing on deviation investigations.

Technical Skills

• Strong understanding of pharmaceutical facilities, equipment, and systems.
• Familiarity with GMPs, NIH guidelines, and FDA regulatory requirements.
• Proficiency in conducting root cause analyses and implementing corrective actions.
• Intermediate computer skills and the ability to manage technical documentation.