Benjamin Williams

A Quality Assurance (QA) Inspector II at Kindeva Drug Delivery in St. Louis, MO, is responsible for ensuring the quality of drug delivery products throughout the manufacturing process. They perform in-process inspections, review production records, and communicate non-conformances, ensuring compliance with cGMP regulations and company procedures. The role also involves participating in aseptic processing activities, gowning, and maintaining a clean and compliant work environment.

Key Responsibilities:

• In-Process Inspections: Perform inspections of components, assemblies, and drug product containers during manufacturing.
• Batch Record Review: Review production batch records for accuracy and adherence to procedures.
• Non-Conformances: Communicate and document any non-conformances found during manufacturing.
• Aseptic Processing: Work in a Grade A/B classified area, understanding and demonstrating aseptic techniques.
• Documentation: Generate daily shift reports and update procedures as needed.
• Compliance: Ensure adherence to cGMP regulations, company policies, and procedures.
• Training: Train floor quality assurance colleagues.
• Shift Work: Work third shift, including weekends (Saturday and Sunday), and be willing to work overtime.

Required Skills and Qualifications:

• Experience: Relevant experience in a QA or QC role, preferably in a pharmaceutical or biotech manufacturing setting.
• Aseptic Processing: Knowledge of and experience with aseptic processing techniques.
• cGMP: Understanding of cGMP regulations and guidelines.
• Communication: Strong communication and documentation skills.
• Teamwork: Ability to work effectively as part of a team.
• Attention to Detail: High attention to detail and accuracy.
• Training: Must be able to complete aseptic gowning qualification.

• Maintains quality standards by approving incoming materials, in-process production, and finished products; recording quality results.
• Verify incoming product by RA # and incoming paperwork.
• Approves final incoming product by confirming specifications, conducting visual and measurement tests.
• Prepare material by loading product on vertical rewinding machine, preparing to thread plank through the UT scanning mechanism, aligning above mirror for visual examination of pultruded plate.
• Document any irregularities emphasized by UT scanning mechanism.
• Document inspection results by completing reports and logs; summarizing re-work and waste; inputting data into quality database.
• Comply and assist with enforcing all Company/Safety policies and procedures.
• Operates a 4-point harness overhead crane to transport product.
• Need to document final length/weight.
• Prepare labels, and other shipping documentation.
• Operates binding equipment, according to specifications move product to shipping area.
• Additional duties are assigned as needed.

• Job duties: responsible for all aspects of setting up and running the production equipment, maintain the product flow process and procedures, and ensures consistent, efficient, and effective workflow through the department and demonstrate safe work practices at all times, staying focused on maintaining a safe work environment.
• Follow all food safety required procedures, check quality characteristics while operating equipment while operating production machine, including troubleshooting, cleanup, setup, basic quality control, and waste control following all necessary GMPs and ensure workers on the line are following GMPs.
• Work with Maintenance Team to troubleshoot minor machine problems, observe and follow safety procedures using personal safety equipment and lock-out/tag-out procedures as required.
• Perform hourly quality checks on finished goods enter data into Flex System, assist in production performing packaging duties as needed or requested.
• Provide support work for plant improvement projects as directed proper use of fish grinding and seed blending machinery and metal detector.
• Understands recipe sheets usage policy and procedure, conduct quality competency-moisture quality control test, consistency, color, weight, etc.
• Troubleshooting minor machine problems, setup and adjust machinery as needed, pick components for batches from warehouse stock, perform clean out procedures between product runs, produce high quality batches and ensure accurate batch/inventory tracking.
• Assist with monthly inventories as needed, comply with all company policies and procedures, complete other duties as assigned.

• Job Duties: Setup high speed manufacturing equipment, within defined tolerances, to ensure product runs are started on time and within established guidelines.
• Comply with all safety policies and procedures at all times, appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
• Responsible for the operation of high speed equipment used in the production and packaging of VITEK 2 cards in a GMP compliant manner.
• Assist in the setup, operation, inspection, maintenance, execute production activities per approve manufacturing directions while maintaining compliance with all job relate SOPs.
• Ensure that all batch paperwork is completed in a an accurate, thorough, and timely manner.
• Execute validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as required to maintain systems in a validated state.
• Provide assistance with the review and revision of manufacturing directions and SOPs necessary for the manufacture and packaging of product.
• Troubleshooting and cleaning of equipment use throughout the VITEK 2 Card Manufacturing and Packaging processes.
• Completing production batches and corresponding documentation for the associate task, (AQL) Acceptance Quality Limit inspections, reworks and material reconciliation that goes along with the batch.
• Engage in cage movement, maintain product segregation, retrieve and organize raw materials, follow appropriate departmental cleaning procedures to ensure adequate cleaning of the manufacturing areas.
• Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with GMP requirements.
• Perform other duties assigned by Management.

• Job Duties: Process hotline calls and daily emails.
• Date stamp work and daily distribution to employees for processing.
• Perform weekly and yearly staff evaluations.
• Train new staff upon arrival.
• Assist the Unit Secretary and Program Managers on a daily basis as needed to help meet deadlines.
• Process & make payments to state vendors for the record Management unit.
• Attend daily management meetings for CQI, schedule & direct weekly meetings for my employees and monthly meetings for monthly evaluations.
• Assist with preparing cases for archives in Jefferson City with the SMART System.
• Monitor daily employee attendance performance.
• Approve employee’s time and leave requests in the Leave Track Systems.

• Job Duties: To participate in the new hire interview panels and the clerical exam design committee.
• To provide supervisory coverage to intake and employment units.
• To establish work priorities and direction on difficult clerical problems to clerical staff.
• Confer with superiors on office procedures; prepare legal documents, statistical data and reports.
• Inspected operating equipment and ergonomic support for all employees.
• Conducted daily Benefits Meetings.
• Assist with escalated client calls.
• Filled in as necessary at the Information Desk, Customer Contact Units and the Fingerprinting Room.
• Handled employee time keeping and break schedules.

• Job Duties: To hire, train, coach & develop a staff of employees of various socio-economic and ethnic groups.
• To create & maintain financial ledgers, monthly budget records, equipment and supply inventory spreadsheets, miscellaneous expenditures and financial transaction receipts for banking purposes.
• Monitor, review and evaluate staff performance.
• Effectively resolve or mediate personnel issues.
• Create & establish process & procedures to insure the constant fluidity of scheduling clientele to avoid any disorganization.
• To maintain a safe, sanitary and business professional environment.