Role requires to be on site in: Omaha, NE full time.

Streck provides:

• A challenging, safe and rewarding work environment
• No night or weekend shifts
• Excellent work life balance
• Affordable, high-quality apartments for employees
• Market competitive pay
• Comprehensive and inclusive benefits
• Great team environment
• On and off campus career development opportunities

Summary of Responsibilities:

This position will be responsible for quality activities performed in their assigned department(s) and ensuring compliance with regulatory requirements and internal procedures. Under general supervision, this position provides day-to-day quality support to the designated departments.

Essential Duties and Functions:

1. Assures that any observations/deviations are properly investigated and explained.
2. Provides assistance with Deviation and Nonconforming Product/Material Reports. Responsible for evaluating Error Deviations and Error IP/FP Nonconforming reports to identify potential gaps in the quality system.
3. Responsible for investigating quality matters by leading RCA meetings in the CAPA process, assisting with CAPA plan implementation and Effectiveness Checks.
4. Assists with implementation of significant process changes from a Change Control through supplemental training and/or direct observation the first time the new procedure is performed.
5. Provides Quality skillsets training to all new hires and serves as a quality leader in their assigned area of responsibility.
6. Performs biannual audits of equipment in assigned areas to ensure appropriate status in Reliance.
7. Maintains awareness of activities by routine direct observation of processes. Interacts frequently with Operations staff to provide quality perspective on routine operations and error prevention. Addresses conditions/practices with appropriate personnel, and documents and reports finding to Management.
8. Assists departmental supervisor(s) with generating outstanding training reports for individuals in the area.
9. Assists with writing and revising Standard Operating Procedures as necessary.
10. Collects and analyzes data to understand trends and issues and maintains Quality System reporting tools such as error tracking spreadsheets and other metrics as requested by management.
11. Cultivates a culture of continuous process improvement and participates in quality and process improvement initiatives and project validation teams.
12. Establishes regular meetings to communicate quality metrics and present potential focus areas to QA Manager and QC/Production Managers/Supervisors as necessary.
13. Assists with the final assembly and retention of the Device History Record.
14. Performs all other duties as assigned by manager.

Manufacturing:

1. Performs critical timeline checks and in-process reviews such as diluent checks, incubator temp checks, etc., as required by process documentation.
2. Performs batch record/lot file reviews in accordance with good documentation practices and internal procedures in an efficient and timely manner.

Fill:

1. Performs Re-inspection Approval to ensure product re-inspects are completed and the vial quantity is documented appropriately.
2. Performs final Lot File Review of all Device History Records to verify accuracy and completeness of files.
3. Reports on Process Limitations and distributes to management for review.
4. Performs In-Process Lot File checks to review paperwork during in-process activities (sign-off on equipment set up, fill checks, etc.).

Distribution:

1. Performs inspections in accordance with established procedures and sampling plans to ensure all packaged products/devices meet internal and external quality specifications pertaining to packaging and shipping operations.
2. Performs packaging line clearance checks and Distribution record reviews in accordance with good documentation practices and internal procedures in an efficient and timely manner.
3. Assists with daily cycle count inventory investigations.

QC/Lab:

1. Performs final Lot File Review of QC Device History Records to verify accuracy, adherence to good documentation practices and internal procedures, and completeness of files.
2. Reviews all QC instrument maintenance and reagent logs and follow-up activity.
3. Performs whole blood calibration event and value assignment reviews for accuracy and completeness.
4. Performs 5S lab audit and reports observations to QC management.

BCT Facility:

1. Conducts incoming commodity inspections based on established sampling plans on tubes, stoppers, labels, etc.
2. Performs in-process verifications for reagent volume and tube vacuum throughout the production run.
3. Perform in-process checks to approve printed labels prior to application.
4. Performs batch record/lot file reviews in accordance with good documentation practices and internal procedures in an efficient and timely manner.
5. Performs packaging line clearance checks and Distribution record reviews in accordance with good documentation practices and internal procedures in an efficient and timely manner.
6. Performs final inspections in accordance with established procedures and sampling plans to ensure all packaged products meet internal and external quality specifications pertaining to filling, labeling, and packaging and shipping operations.

Position Requirements include:

• Minimum education level of an Associate degree required.
• Bachelor's degree in STEM or related discipline preferred. Relevant experience (2-3 years) in a quality role, preferably in an FDA or USDA industry, may substitute for technical education.
• Minimum of one to four (1-4) years of related work experience in an FDA regulated manufacturing environment.

Technical Competencies:

• Strong PC skills and knowledge of Microsoft applications particularly word and excel.
• Quality auditing certification preferred.
• High attention to detail.

Work Environment/Travel Demands:

The work environment is a climate-controlled biological/chemical laboratory. Occasional short durations to cold temperatures inside walk-in coolers. Ability to wear required laboratory clean room clothing (laboratory coats, hair bonnets, and beard covers (as applicable) and other safety/protective equipment (masks, gloves, and/or face shields for example) for up to two and a half hours consecutively. Travel demands for this position are estimated up to 5%. If travel is required, this travel may include training/professional development, customer visits, events/trade shows, and completion of presentations primarily throughout Domestic US or International regions. Employees must comply with all travel recommendations regarding "safe travel" according to company policies and guidelines, and all federal, state, local, and international orders.

**PHYSICAL/MENTAL DEMANDS:

Medium work exerting up to 55 pounds of force occasionally and/or up to 10 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. This also includes standing for up to two and a half hours consecutively, walking, pushing, pulling, lifting, reaching, stooping, fingering, and grasping. Expressing and receiving detailed information through written and oral communication. Also has an ability to make sound, appropriate, and prompt decisions within the guidelines of the role.

**The work environment characteristics and physical demands stated in their respective sections are representative of those necessary to perform the essential functions of the job. Reasonable accommodations will be reviewed and considered. If approved, accommodation may be made to enable individuals with disabilities to perform the essential functions of their assigned role.

The above statements are intended to describe the general nature of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Visit to learn more about Streck and apply for this opportunity.

Streck is an Equal Opportunity/Affirmative Action employer and forbids discrimination against any employee or applicant because of race, color, religion, gender (including pregnancy, gender stereotyping and caregiver status), sexual orientation, gender identity, transgender status, national origin, disability, genetic information, citizenship, marital status or status as a covered veteran in accordance with applicable federal, state and local laws.