Associate Analyst, QC Control Center(C9904)
Purpose and Scope of Position
The Associate Analyst, QC Control Center is responsible for assisting with maintaining the daily operations of the QC Control Center. This position is responsible for receiving and distributing samples, standards and worksheets used for analysis of raw material and product samples. The Associate Analyst under guidance provides assistance with the Stability and Reserves Programs. The incumbent assures individual compliance with FDA regulations, cGMP’s and applicable department programs, including training, documentation, standard operating procedures, and BMS policies and procedures.
2. Required Competencies: Knowledge, Skills, and Abilities
Basic knowledge of electronic document management systems (CelDox, Compliance Wire).
Ability to work independently for extended periods of time.
Basic PC skills
Basic math skills
Basic knowledge of cGMP, OSHA, USP, and EP.
Basic written and verbal communication skills.
Basic strategic thinking and the ability to work independently.
Basic organizational and time management skills.
Strong attention to detail.
Ability to follow directions and report problems to designated senior personnel.
Ability to collaborate with peers on day-to-day tasks; cooperative and works well with a team.
Ability to communicate effectively with peers, department management and cross-functional
Actively seeks opportunities to learn.
3. Duties and Responsibilities
Provide customer service to impacted site departments.
Receives samples for distribution QC Laboratories.
Manages the accountability of samples.
Issues documents for testing in the QC Laboratories.
Files completed documents returned from the QC Laboratories.
Assists with service contracts and purchase requests as needed.
Reserve Program Involvement includes but not limited to:
Delivery of samples/components to appropriate storage areas.
QA Evaluation assistance
Stability Program Involvement includes but not limited to:
Assist with Stability Pulls
Receiving stability samples
Stability sample destruction
Maintain laboratory reagent, consumables, and standard inventories
Ensure standard inventories are completed inventory maintained.
Assist in the receipt of laboratory reagents and supplies.
Performs other duties as assigned.
4. Education and Experience
High School Diploma or equivalent required.
3 years in a regulated industry required.
An equivalent combination of education and experience may substitute.
5. Working Conditions
The incumbent will be required to type for up to 2 hours per day.
The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs. for 2 hours, approximately 3 times per week.
The incumbent will be required to stand for extended periods of time, up to 4 hours per day.
The incumbent must be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
The incumbent will be working around hazardous materials to include chemical agents at least 8 hours per day.
The incumbent will be working inside a chemistry laboratory, at a computer terminal, up to 4 hours per day.
The incumbent often works for extended periods alone, up to 6 hours per shift.