PDS Tech, Inc. Jobs

PDS Tech is seeking candidates for a Sr QA Technician position in Austin, TX

How will you make an impact?

This position will be responsible for ensuring quality operations with respect to manufacturing, filling, packaging and inspection.

Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Primary responsibilities require consistent production floor presence which necessitates physical fitness for prolonged standing, walking, and repetitive bending. As a Sr QA Technician, you will help to ensure the Austin site meets all the requirements for ISO-9001, ISO-13485, 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA), Quality Systems Regulation (QSR) and USDA regulations.

You will partner with various Operations teams to support on-time delivery of quality product through the following activities:

What will you do?

• Perform daily quality assessments to uncover errors or deficiencies and assure quality and compliance as required by site procedures and cGMP and IVD.

• Daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance

• Fosters quality culture by aiding personnel in understanding application of policies and controls

• Ensures escalation of deviation events to the appropriate area and quality management

• Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity

• Performs quality review and approval of deviation and change control of low to moderate complexity

• Participates as the quality assurance representative in root cause analysis to support deviation investigations of low to moderate complexity

• Performs quality batch record review

• Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives

• Perform Batch Record Review and help with Product Release

• Archival of manufacturing and QC records

• Sample Retain management

• Recommend improvements to processes and procedures; may help revise procedures.

• Perform other duties to support the Quality department as assigned.

• Duties will include complaint handling, will work with cross functional department on complaint cases for investigations, root cause analysis, and corrections/corrective actions to ensure proper documentation and closure, provide trending and escalations as appropriate

• Participate in internal audits per ISO 13485 and 9001 requirements and ensure site audit readiness

• Support internal Quality activities concerning any identified nonconformities

• Participate in departmental projects and improvement initiatives through the site’s PPI Program and partner with other groups to continuously improve

• Prepare clearly written business communications, including audit reports, gap assessments, validations, etc.

• Generate and fulfill customer request for COAs, COCs, COOs

• Perform other duties to support the quality and regulatory department as assigned.

• Creating problem reports for nonconforming raw material

• Ensuring discrepancies are thoroughly identified, defined and properly assessed.

• Interacting with interdepartmental contacts on change and discrepancy assessment, resolution, and quality approval.

• Providing timely information to Operation.

• Update and meet metrics

• Identifying opportunities for continuous improvement of the Quality Systems and participate on implementation.

• Maintain calibrated tools and equipment

• Be able to communicate technical issues and inspection results orally and in writing.

• Ability to work independently and as part of the QA Team

• Sense of urgency with completion of projects and tasks

• Serves as a backup for other Quality positions as needed

How will you get there?

Education:

• Bachelor’s degree, preferably in technology, engineering or science related field

• Associates degree, minimum in technology, engineering or science related field

• Equivalent combinations of education, training, and relevant work experience may be considered

Experience:

• A minimum of 2 years’ experience in Quality Assurance or Quality Control, Operations/Manufacturing or equivalent

• Previous experience in pharmaceutical industry; preferably GMP/IVD experience strongly preferred, experience in other regulated environments a plus (i.e. ISO 9001)

• Professional certifications (ex: CQA, ASQ) and training (Six Sigma) are a plus

• SAP, Trackwise, AGILE experience are a plus

Knowledge, Skills, Abilities:

• Ability to gather data, analyze & troubleshoot process issues, equipment problems along with production leadership

• Self-driven, demonstrated ownership & responsibility; Ability to lead, support & motivate a team

• Technical Writing experience preferred

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.