Quality Specialist - College Station, TX

The Quality Specialist oversees product-level quality programs including raw material and finished good specification set up and change control processes, product release testing, and customer requests. They will assist with product investigations. The Quality Specialist will work closely with Document Control, Quality Control, Planning, and Production as a team to ensure timely completion and documentation of associated tasks.

The Quality Specialists will become knowledgeable in Federal and other regulatory agency requirements, customer requirements and cGMPs to assure that product specific documentation are in compliance, and will train on and gain competency in activities to facilitate regulatory compliance. 

Specific responsibilities include but are not limited to the following:

Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and proceduresMaintain current knowledge base of existing and emerging regulations, standards, or guidance documentsCreate or complete customer-required documentation requested through regulatory requestsRecommend changes to company procedures in response to change in regulations or standardsPerform and maintain a quality risk assessment and provide timely recommendations and projects in response to emerging issues related to the companySupport investigations and determine and execute testing plans.Reviews and compiles data to support the release of product.Collaborates with team members in the identification and implementation of continuous improvement initiatives and action plans.Other duties as assigned.

Education

Preferred – 4 year university degree in science, biotechnology, microbiology, or other related field.

Experience

Experience working in an FDA regulated environmentKnowlede of FDA BAM methodologies.

Specific skills

Ability to take initiative to maintain confidentiality, to meet deadlines, and to work in a team environmentLeadership skillsMust be able to manage multiple projects at onceMust have the ability to assess situation and develop a solutionMust have good attention to detailMust have the ability to adjust to changing work demands and priorities in a fast paced environmentEffective communication and report writing skills; legible handwriting requiredExperience with Microsoft Office products with an emphasis on ExcelStrong analytical experienceAbility to learn new technologies quicklyResults driven, strong work ethicStrong organizational and time management skillsAbility to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Must be able to walk, bend, kneel, stoop, climb, reach and grasp for varying periods of timeAbility to differentiate subtle variances in colorFluent in English requiredMust possess a valid US driver’s license.Excited about this role but don’t think you meet every requirement listed? We encourage you to apply anyway. You may be just the right candidate for this role or another one of our openings.

ADM requires the successful completion of a background check. 

REF:94361BR