Laboratory Supervisor

If you're looking for an opportunity to be challenged in your career, this may be the job for you. BioSpectra, Inc. is experiencing unprecedented growth and is looking for a Laboratory Supervisor to support the daily activities of the Laboratory Testing department.

BioSpectra, Inc. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA, and Scarborough, Canada.

Why should you join BioSpectra, Inc.?

Support our current customers who are the top 25 pharmaceutical companies in the world
Develop your career with a growing organization with ample opportunities for professional and personal development
Comprehensive Benefits Package (Medical, Dental, Vision, Company paid Life Insurance, Tuition Reimbursement)
401K Retirement Savings Plan - Company matches $2 per $1 of employee contribution on the first 4%
Excellent Paid Time Off Programs include vacation, sick, & personal time, plus paid holidays

Job Summary:The Laboratory Supervisor is responsible to supervise and direct the day-to-day activities of the Laboratory Testing department.

Major Roles & Responsibilities:
Direct Reports: QC Analysts

• Responsible for supervising the activities of the analytical staff in a cGMP QC laboratory environment
• Direct/Coordinate the quality lab activities to plan and establish work schedules, and assignments in support of production and organizational goals
• Support laboratory staff; access to training, manage performance and development of staff
• Reports on performance, and metrics for each analyst to Laboratory Manager
• Ensures that all testing is performed in a timely manner and with accuracy to support the release of the product
• Initiates and Performs laboratory investigation when necessary based on the outcome of testing performed.
• Ensures raw material testing for approval and supply chain management is performed, documented, and communicated to the appropriate departments as needed
• Assists with new product development and timelines
• Ability to write/execute protocols, and write reports for method validations
• Perform the qualifications and validations of test methods, and instruments
• Performs impurity, supplier approval, and research testing
• Troubleshoots and maintains instrumentation
• Develop, maintain and communicate all applicable SOP's (Standard Operating Procedures)
• Maintains proper record keeping, calibration, and repair of analytical instruments to ensure compliance with GLP and GMP
• Reviews and approves laboratory notebooks
• Maintains inventory and ordering of laboratory supplies
• Maintain all housekeeping, regulatory and GMP requirements
• Other duties may be assigned as deemed appropriate by management.

Qualifications:

• Bachelors of Science degree in Science or related field
• 2-5 years previous quality laboratory experience in a fast-paced regulated manufacturing environment preferred.
• Must possess excellent communication (oral and written), organizational, and interpersonal skills with the ability to multitask while working under restrictive timelines.
• Must be proficient with MS Office applications
• Prior experience working in a cGMP/GLP environment required
• Solid critical thinking skills and ability to create new, innovative ways to handle the quality function
• Must be able to read, write, speak, and understand English
• Ability to maintain absolute confidentiality at all times and in all situations
• Must be able to lift, bend, stoop, reach, climb ladder, sit or stand throughout shift
• Must be able to distinguish color and color change

Physical Requirements:

• Lift up to 20 lbs.
• Bend, stoop, carry, and reach
• Climb and/or stand on an elevated bench or step stool
• Sit and/or stand for extended periods
• Ability to see and distinguish color
• Work with chemicals and/or hazardous materials

Work Hours:

Exempt Position; Monday to Friday 3 pm to 11:30 pm; Occasional off-shift work

Minimum of 40-45 Hours per Week, or other agreed-upon documented schedule

This position requires occasional travel to and working from other BioSpectra facilities, as well as occasional off-shift work