Position Summary:

• Manage the receipt, storage, organization, and disposal of Controlled Substances within the Quality Control Laboratory Setting. The individual ensures compliance with FDA and DEA regulations in a high-growth, fast-paced, dynamic work environment.
• Receiving and logging Controlled samples into LIMS while ensuring compliance of QC practices.
• Receiving Controlled samples into the Electronic Batch Record system to maintain sample chain of custody
• Help maintain a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid back logs.
• Performs other duties as assigned or apparent.

Primary Accountabilities:

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• Receives samples and logs them into LIMS or documents them on the appropriate forms.
• Receives samples using the Electronic Batch Record system to ensure proper chain of custody for controlled substances.
• Primary point of contact for analyst to acquire controlled substance samples for testing.
• Distributes, bags, and labels samples according to required testing needs ensuring sample management.
• Responsible for maintaining organization in sample receiving.
• Maintains an organized and clean sample storage area for all active and tested samples.
• Communicates with appropriate persons concerning ID or Lot number discrepancies.
• Reconciles laboratory samples and standards after testing to ensure sample accountability.
• Completes waste destruction forms and submits and files them accordingly.
• Disposes of sample waste in a timely manner.

Knowledge, Skills & Abilities:

• Minimum High School Diploma or GED.
• Good communication skills.
• Strong organization skills with the ability to handle numerous details.
• The ability to use a computer and different programs efficiently.
• Experience with cGMP documentation systems and with implementation of quality control systems.
• Knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.
• 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 time frames.
• The ability and willingness to change direction and focus to meet shifting organizational and sample demands.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.
• Salary range: Based on experience