Quality Control Chemistry Sample Management Coordinator

QC Chemistry Sample Management Coordinators are to manage the receipt, storage, organization, and disposal of Analytical Services laboratory samples in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA and DEA regulations. The qualified individual will be responsible for receiving and logging samples into the company’s Laboratory Information Management System (LIMS) while ensuring compliance of QC practices. The qualified individual will assist in maintaining a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid backlogs. The individual will assist with additional work duties or responsibilities as evident or required.

Essential Duties and Responsibilities:

• Receive and log samples in accordance with SOPs and GMP requirements through LIMS or other tracking systems.
• Distributes, bags, and labels samples according to required testing needs ensuring sample management.
• Maintains organization in sample receiving.
• Identifies samples needed for outside testing and follows procedures for shipping to third party labs.
• Maintains an organized and clean sample storage area for all active and tested samples.
• Communicates with appropriate persons concerning ID and lot number discrepancies.
• Completes waste destruction forms and submits/files them accordingly.
• Oversee and supervise sample waste disposal within the laboratory.
• Recognize and initiate any continuous improvement opportunities in sample handling, documentation, or communication processes to improve efficiency, accuracy, and compliance throughout the sample lifecycle. 

Supplemental Functions:

· Assist with the overall cleanliness of the QC laboratory to ensure compliance with all cGMP requirements.

· Provide guidance to management to resolve all QC compliance-related observations, issues, problems, discrepancies, and violations of company policies/procedures.

Performs other similar duties as assigned or apparent 

Job Specifications and Qualifications:

• Experience using LabVantage or similar software preferred.
• Ability to use a computer and different programs efficiently.

Knowledge & Skills: 

• Must be detailed oriented and have excellent organizational skills.
• Must possess effective written and oral communication skills and be able to handle multiple tasks within limited timeframes.
• Knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.
• Ability and willingness to change direction and focus to meet shifting organizational and sample demands.
• Ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• Ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals. 
• Ability to effectively manage a multitude of resources and to be accurate and current with data and information.
• Well-developed knowledge of the consumer/customer demonstrated through continuous efforts to exceed their expectations.
• Broad perspective that aligns decisions to organizational objectives and      long-term consequences of day-to-day activities.
• Ability to take strategic objectives and accept accountability, motivate, and      influence others, thinks globally and leverages diversity.

Education/Experience:

• Bachelor’s degree in Science or related field required (Chemistry, Microbiology or Biology).
• Experience with cGMP documentation systems and with implementation of QC systems.
• Specific expertise, skills and knowledge within laboratory compliance gained through education and experience.
• Salary range: Based on experience.  

Working Conditions / Physical Requirements:

• Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting, walking, and hearing.
• Position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids and other non-specified hazardous materials that are project specific.
• Position requires lab coats, safety glasses, respiratory and other non-specified protective equipment to be worn as necessary.