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.

• 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

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).

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.

• 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 perception and ability to adjust focus.
• While this position will primarily work in a manufacturing & laboratory environment, this position may require travel specifically pertaining to company events, staff meetings, training sessions & vendor fairs. May be required to utilize personal vehicles for business travel that may result in long periods of sitting.
• The noise level in the work environment is usually moderate.
• This position may require over-time.
• This position is occasionally exposed to wet and/or humid conditions, elevated ambient temperature, moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals and outside weather conditions.

NOTICE: The above statements are intended to describe the general nature of the environment and level of work being performed by this job. This questionnaire in no…