This position reports to Swing (2nd) shift. This shift schedule is Monday to Friday 2:00 PM to 10:30 PM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
Responsible for coordination (pick-up, receipt, aliquot, distribution and shipping) of in-coming bulk, intermediate, final containers, final package, stability and validation samples. Perform data entry and data collection. Perform daily lab support operation activities (e.g. material, supply and chemical inventory and replenishment, kitting, glassware washing, autoclaving, depyrogenation of labware, biohazardous waste removal and QC Documentation Control) to ensure availability of samples, materials and documentation for QC Labs to meet operational testing turnaround times using Lean Principles. Emphasis on continuous improvement and cost effectiveness in daily activities. Participate and/or drive completion of responsible tasks and improvement projects.
Essential Duties and Responsibilities
- Pick up, receive, aliquot, and distribute samples to the appropriate laboratories for testing by following SOP and using GMP/ GDP/ LIMS.
- Support in troubleshooting of issues as they arise from daily tasks, such as sample management, documentation management, inventory management and other lab support activities.
- Perform lab support activities such as supplies inventory management, supplies ordering and replenishing, managing services requests for Lab equipment, kitting, glassware washing, depyrogenation of labware, autoclaving, and lab wastes removal.
- Ship samples to external laboratories for testing in a timely and accurate manner.
- Use Global LIMS or other computerized systems for sample receipt, data entry and data approval.
- Responsible for managing laboratory documentation including the creation, issuance, and archiving of test data packets, test requests, and other QC related documentation.
- Actively contribute to a team setting within the laboratory and potentially work with other work teams to drive continuous improvement such as, increasing process efficiency, problem solving, generating cost savings, improving quality compliance, and providing support to new product or process.
- Ensure laboratory area is maintained in a GMP and GLP state at all times while following all EHS,lean and regulatory guidelines.
- Operate laboratory equipment. Ensure that equipment maintenance and operation history is properly documented in a timely manner.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
- Follow Lean principles such as Just in Time Supply replenishment and 5S throughout daily work activities.
- Ensure personal training requirements are met and that training records are current.
- Familiarity with cGMP/GDP and general FDA regulations is preferred.
- Ability to complete tasks in a timely manner and take on additional assignments as needed.
- Good teamwork and communication with internal and external customers
- Good organizational and time-management skills.
- Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office).
- Must be detail-oriented, conscientious, and responsible.
Education and/or experience
High School diploma or equivalent, AA Degree preferred, with some related experience in a quality laboratory setting or a related field.
- Must be able to lift, push, pull and carry up to 25 lbs.
- 20/20 near vision required (corrected is acceptable).
- In general, the position requires a combination of walking to pick up samples from various sample collection locations in manufacturing throughout the day as well as performing inventory, stocking, dishwashing, autoclaving etc. of laboratory materials. There may be some sedentary work as assigned.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Required to work with biohazardous or hazardous waste removal/transferring.
- May be required to work in a cold, wet environment.
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required.
- May be required to work in a confined area.
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