Quality Specialist College Station TXNATURE & SCOPEThe Quality Specialist role combines the responsibilities of ensuring productlevel quality programs and overseeing highlevel fermentation processes at a sporebased probiotic fermentation manufacturing plant. This role will focus on contamination investigations cleaning validations process improvements media development and other advanced fermentation activities. The individual will minimize routine testing emphasizing strategic and scientific contributions. They will work closely with Document Control Quality Control Planning and Production to ensure the timely completion and documentation of tasks maintaining compliance with regulatory standards and improving process efficiency. This position will work under the direct guidance of the Fermentation Site Manager for process improvement and R&D functions.
MAJOR ACCOUNTABILITIESThe Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements customer requirements and cGMPs to ensure compliance. They will train on and gain competency in activities to facilitate regulatory compliance and process improvements. Specific responsibilities include but are not limited to the following:
- Interpret regulatory rules or rule changes and ensure they are communicated through corporate policies and procedures.
- Maintain current knowledge base of existing and emerging regulations standards or guidance documents.
- Create or complete customerrequired documentation requested through regulatory requests.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Perform and maintain a quality risk assessment and provide timely recommendations and projects in response to emerging issues related to the company.
- Support contamination investigations and determine and execute testing plans.
- Conduct cleaning validations to ensure the integrity of the fermentation process.
- Develop and optimize media formulations for improved fermentation outcomes.
- Implement and monitor process improvements for enhanced productivity and quality.
- Calibrate equipment to ensure accurate and reliable results.
- Maintain quality data including production and QA testing and report to leadership as appropriate.
- Prepare Certificates of Analysis (CoAs) for product release.
- Collaborate with team members in the identification and implementation of continuous improvement initiatives and action plans.
- Review and compile data to support the release of products.
- Other duties as assigned.
JOB PROFILEEducation- Required: Bachelors degree in science biotechnology microbiology or other related fields.
- Preferred: Masters/PhD.
- Preferred: PCQI (Preventive Controls Qualified Individual).
Experience- Experience working in an FDAregulated environment.
- Knowledge of FDA BAM methodologies.
- Experience in fermentation science and process development.
Specific Skills- Ability to take initiative maintain confidentiality meet deadlines and work in a team environment.
- Leadership skills.
- Must be able to manage multiple projects at once.
- Must have the ability to assess situations and develop solutions.
- Must have good attention to detail.
- Must have the ability to adjust to changing work demands and priorities in a fastpaced environment.
- Effective communication and report writing skills; legible handwriting required.
- Experience with Microsoft Office products with an emphasis on Excel.
- Strong analytical experience.
- Ability to learn new technologies quickly.
- Resultsdriven strong work ethic.
- Strong organizational and time management skills.
- Ability 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 time.
- Ability to differentiate subtle variances in color.
- Fluent in English required.
- Must possess a valid US drivers license.
Before applying for an exempt nonexempt or hourly job opportunity you are expected toinitiate a discussion and share your intentions with your supervisor. * If youve been in your current position for more than 18 months supervisor approval is not required. * If youve been in your current position for less than 18 months verbal supervisor approval is required.
Hiring Manager Scott Backes
Recruiter Ashley Medina
About ADM At ADM we unlock the power of nature to provide access to nutrition worldwide. With industryadvancing innovations a complete portfolio of ingredients and solutions to meet any taste and a commitment to sustainability we give customers an edge in solving the nutritional challenges of today and tomorrow. Were a global leader in human and animal nutrition and the worlds premier agricultural origination and processing company. Our breadth depth insights facilities and logistical expertise give us unparalleled capabilities to meet needs for food beverages health and wellness and more. From the seed of the idea to the outcome of the solution we enrich the quality of life the world over. Learn more at .
Base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. Hourly and salaried nonexempt employees will also be paid overtime pay when working qualifying overtime hours.
If hired employees will be in an atwill position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
The pay range for this position is expected to be between:
Required Experience:
Unclear Seniority