Quality Assurance Engineer

Description

Neos Therapeutics is a specialty pharmaceutical & nutraceutical company that focuses on time-release technologies. We have developed a broad, cutting-edge portfolio of processes that allow for tailored and independent release profiles of single and multiple ingredients. At Neos Therapeutics innovation is about creating quality products that are both unique and valuable. Our team is committed to providing company`s with quality products and a true partnership - something very difficult to find in today`s world of contract manufacturing. Thrive with Neos.   

 

The Quality Assurance Engineer's at Neos are technical professionals. They assists in the development, improvement, and implementation of the organization’s Quality System under the direction of Quality Management.

Requirements * Improve existing and develop new quality processes through writing and implementing associated procedures and other documentation.
* Provide technical support for improvement of product and process capability based on company and supplier metrics.
* Act as administrator or custodian for various quality processes such as Change Control, Supplier Quality System, Non-Conformances, etc.
* Provide leadership and supervision for various quality personnel as assigned.
* Develop, write, and coordinate execution of protocols for equipment qualification and process validation.
* Provide training and guidance to ensure compliance with protocols, Standard Operating Procedures (SOPs), and other governing documentation for Operations and Quality personnel.
* Conduct investigations of undesirable trends in production process performance and unplanned events, perform root cause analysis, and develop and implement corrective and preventative actions.
* Review of product batch documentation for accuracy, completeness, and specification adherence to determine acceptability for release.
* Flexibility within the quality system to perform various responsibilities upon request.

* Perform other related duties as required.

 

Education:

Bachelor’s Degree

 

Experience:

Two plus years related experience

 

Language:

Ability to read, understand, and communicate instructions and written procedures.  Ability to review and revise documents with proficient grammar and spelling skills.  Ability to write technical reports and correspondence.  Ability to speak effectively before groups.

 

Mathematical:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

 

Reasoning Ability:

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.  Exhibits the competence to perform tasks requiring analytical and problem solving skills.

 

Computer Operations:

Proficient

 

Leadership:

This position demonstrates leadership through the ability to recognize and organize priorities and effective completion of assignments within an allotted time.  The candidate must also understand and promote cGMP compliance and quality in all functions.

 

Supervision:

Receive very general guidance with respect to overall objectives; work is usually quite independent of others; operate within division or department policy guidelines using independent judgment in achieving assigned objectives.