QA Laboratory Technician L1

JOB SUMMARY
The QA Bulk Laboratory Technician is responsible for examining bulk batches coming from Compounding; if out of specification, it provides instructions to Compounding to remediate. Releases or rejects batches, depending on laboratory results. Maintain a safe working environment. Follow safety guidelines & GMPs related to personal hygiene and handling of raw materials & equipment in order to maintain safety standards.

RESPONSIBILITIES

• Provide technical, customer relations, and personnel management for major programs and projects.
• Test bulk batches vs. standards and specifications, Adjust batches within specification if required, Release or reject, as appropriate
• Replace stability samples in stability-chamber at appropriate temperatures, Test stability samples according to schedules and report problems/failures to R&D Manager
• Calibrate laboratory instruments daily. And keep external calibrations up-to-date, including: viscometers and certified thermometers annually
• Test line start-up samples as soon as possible, so that Production can start a line
• Keep notebooks up-to-date and signed according to GMP regulations.
• Reviews raw material test data and, if all specifications are met, release materials in the warehouse management system.
• Give bulk micro samples to Micro group to send out for testing, if needed
• Send out samples to customers for their approval before shipping them the product, a create Certificates of Analysis for bulk products being sent out to other companies
• Keep laboratory dye inventory up-to-date by sending dyes that will be expiring within one month out for micro testing, and order additional dye from Sayreville, before inventory in laboratory expires
• Test samples from external contract manufacturers
• Prepare chemical solutions as needed, including acids, bases, and dyes, for laboratory adjustments
• Change stability-chamber charts monthly
• Change status of finished goods in the Warehouse Management System, as needed

QUALIFICATIONS
Education
Bachelor Degree in related science field

Experience
1-year experience in a related manufacturing position

Skills
Type and Proficiency Minimum Required:

• Excellent communication (verbal and written) and organizational skills. Detail-oriented.
• Ability to read and interpret technical procedures and specifications. Ability to effectively present information and respond to questions from management and inter-department staff.
• Capable of working with peers and associates from other departments in a proactive and constructive manner.
• Ability to successfully engage and lead individual and team discussions and meetings.
• Ability to add, subtract, multiply & divide into all units of measure, using whole numbers, common fractions, and decimals.
• Ability to work with little supervision and use independent discretion.
• Ability to operate computerized lab equipment and maintain accurate data/records.
• Strong analytical and problem-solving abilities.
• Team-oriented and able to successfully work independently or in a collaborative/group setting.
• Flexible, adaptable, and capable of working in a fast-paced environment.
• Ability to apply all relevant policies in a consistent, timely and objective manner.
• Ability to handle multiple tasks and shift priorities as necessary. Uses time effectively.
• Gathers and analyzes information skillfully.
• Proficient use of MS Office (Word, Excel and Outlook).

Decision Making Authority
Most important decisions made fully independently:
Determines acceptability of bulk batches

Most important decisions made with review and approval of other individuals or supervisors (include the reviews/approvals required):
Approve or reject bulk batches results.

Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to sit, stand, walk and use hands and fingers to operate a computer keyboard, mouse, and telephone to talk and hear.
• The employee is frequently required to reach with hands and arms and climb or balance.
• The employee is occasionally required to stoop, kneel, crouch or crawl and lift up to 25 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perc