Laboratory Technician VI

Job Summary

The Specialist in Chemistry is responsible for supporting the manufacturing process of Rx and OTC pharmaceutical products in Waco. Knowledge of GMPs and technical writing skills.

This position is responsible for the following

• Provides technical support to Chemistry Laboratory staff in executing stability protocols and conducting testing. Supports laboratory operations and manufacturing activities related to raw materials, in-process materials, and finished products.
• Conducts investigations on out of specification test results.
• Organizes and may perform testing of raw materials (including USP water), bulk samples, and finished product to assure the chemical quality of the product.
• Evaluates stability of raw materials, bulk samples, and finished product per established protocols.
• Interfaces with QA counterparts to optimize laboratory support of QA and production activities.
• Works effectively with chemists to complete special sample analyses as required.
• Preforms other duties as assigned and assists on special projects as required.
• The incumbent is empowered to make decisions and take actions necessary to fulfill job responsibilities. The role requires compliance with applicable ethics, environmental health and safety, financial, human resources, cGMP, and general business policies, requirements, and objectives. The incumbent must also be willing to accept temporary assignments as needed.

Regulated Responsibilities (including cGMP and EHS)

• Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
• Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications & Requirements

• Bachelor's Degree with an emphasis in Chemical or related science.
• 5 years of experience in pharmaceutical manufacturing chemistry lab or similar laboratory experience.
• Intermediate user knowledge of Microsoft Office. Experience with LIMS and Trackwise preferred.
• Experience working in a GMP regulated environment preferred.
• Experience working in an aseptic environment preferred.
• Excellent analytical skills and problem-solving skills.
• Strong math skills, including the comprehension of metric weights and measures, performing complex calculations, and spreadsheet management.
• Ability to perform detailed tasks and document activities accurately.
• Able to work in an aseptic controlled environment which includes wearing PPE, aseptic gowning qualifications, and subsequent gowning requalification's.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts).
• Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
• Ability to read, comprehend, write, and communicate effectively in English.
• Intermediate user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Experience with SAP preferred.
• Strong written and verbal communication skills.
• Ability to work with minimal supervision.
• Ability to provide direction for functional area.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.