Supervisor, Compendial Testing , CDMO

Responsibilities

• Supervises the day-to-day operations for assigned area with raw materials, packaging components and utilities (water and gas) testing using USP/EP/JP/ACS/FCC in a fast paced CDMO environment.
• Ensures all staff members are fully trained.
• Participates in and supports client visits, audits, and inquiries to ensure complete fulfillment of requests and interests.
• Recruits, trains, develops, and retains staff for the effective process of departmental operations.
• Provides technical guidance for troubleshooting and investigating simple to moderately complex issues in the area of expertise.
• Applies statistical analysis for interpretation of project data.
• Safeguards all cGxP data generated for projects according to relevant internal procedures and regulatory requirements.
• Effectively resolves related lab/quality issues and concerns in a timely manner.
• Enforces all laboratory safety, security, and housekeeping policies and procedures.
• Contributes to the preparation and coordination of internal audits and regulatory inspections.
• Builds and standardizes quality systems across sites through active contributions to client interactions.
• Works independently with some direction, promoting a safe environment for work.
• Communicates well orally both internally and externally, writing reports and business correspondence as needed.
• Takes initiative in problem solving and demonstrates enthusiasm and curiosity in tackling challenges.

Qualifications

• Requires a life science degree and 5+ years of relevant operations experience within the pharmaceutical industry testing raw materials required.
• Chemistry degree preferred.
• Prior CDMO experience required.
• May be new to supervising staff but should have some experience managing projects and/or taking lead roles.
• Strong understanding of company SOPs and regulatory guidance documents.
• Strong knowledge of safety procedures and quality compliance for assigned area.
• Experience with USP/EP/JP/ACS/FCC required.
• Thorough OOS/OOT investigations and implementation of appropriate CAPAs.
• Experience with client audits.
• Good knowledge of cGMP requirements.
• Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites.
• Strong analytical and problem-solving skills with the ability to think strategically.
• Strong attention to detail as well as time and resource management.
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
• Ability to communicate well orally both for internal customers and team members as well as external customers.
• Ability to listen and respond well to external customers, partners, and colleagues at all levels.
• Highly goal and result oriented.
• Good team and interpersonal skills.