QA Specialist IV
- Make contributions and guide the completion of milestones associated with specific projects while supporting ongoing quality assurance responsibilities in support of commercial manufacture, testing, and release of product. Independently determine methods and procedures on new assignments while providing guidance to other lower-level personnel. Areas of responsibilities include:
- Review manufacturing and support records to certify compliance with specifications and procedures.
- Work closely with Operations and Quality Control to resolve open issues resulting from record reviews, on the floor walk through activities of the facility, and deviation issues.
- Review and assesses deviations includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
- Review and approves Corrective and Preventive Actions CAPA includes tracking, follow-up, reporting/trending and defining the evaluation of CAPA for effectiveness.
- Representing Quality Assurance to guide various project and technical meetings
- o Continuous improvement project team member performing gap analysis for equipment life cycle and preventive maintenance procedures
- o Process mapping team project member to define, measure, analyze, improve, and control areas of high risk processing procedures that may induce microbial implications
- Capturing and reporting metrics around Quality System and Batch Record review turnaround times and closure/approval times
- Document creation and review, including Standard Operating Procedures, protocols, and reports
- Performing internal audits and data audits, as required
- Providing training to site personnel and contractors on GMP and the Quality System procedures
Manufacturing QA Supervisor
- Primarily responsible for supervising and supporting a team of QA Compliance Specialists with the majority of the time spent on the manufacturing floor. Along with managing personnel, I was responsible for performance and oversight of the following activities:
- Perform record review necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulations.
- Establish auditing requirements, quality standards and test methods in accordance with FDA and GMP requirements.
- Ensure operations documentation meets established requirements for cGMPs, internal SOPs, and company policies
- Conduct review of manufacturing processes to ensure compliance.
- Conduct review of testing results in support of release of intermediates.
- Assist in deviation/nonconformance identification and resolution.
- Participate and/or lead team to investigate deviations to determine appropriate root cause and CAPAs and may be responsible for CAPA resolution.
- Perform validation protocol or final report review to ensure validation criteria and results are appropriate and comply with regulations and current industry standards.
- Interpret complex, explicit documentation to ensure quality standards and compliance ar e met.
- Provide training to new employees.
- Review and approve deviations, environmental monitoring and critical utility investigations, work orders and Metrology discrepancy reports in support of product release.
- Ensure completion of organizational projects and goals.
- Assist in hosting regulatory inspections for the site and participate in the internal audit program, as necessary.
- Review and approve document change requests.
- Prepare product release documentation to support the product release team.
QC Sample Control Records Supervisor
- To supervise and support the day-to-day activities performed by the Sample Control and Records group within the Quality Control organization to support production, testing, and lot release objectives.
- Oversee the execution and maintenance of cGMP policies and guidelines pertinent to Sample Control Records group responsibilities.
- Maintain cGMP lab readiness and compliance at all times
- Management of Quality cGMP samples release, stability, in-process, Reference Standards and controls, reserves and registration samples to support release of Shire HGT commercial and clinical products
- Oversee receipt and distribution of samples between facilities to internal and external customers and testing laboratories
- Support management of contract Labs for in-process and release testing logistics, sample shipments . Also includes oversight of critical reagent supplies including reference standard and assay controls
- Support Quality Control Stability group study enrollment and initiation
- Coordinate distribution of release, stability, and in-process samples to functional labs including aliquotting of samples for testing and release
- Coordinate sample packing, receiving, and log-in of GMP material to/from manufacturing facilities
- Supervise and mentor staff including staff development and coaching, oversight and execution of job responsibilities and functional goals through routine 1-1s
- Management of QC support programs including emergency response groups, QC equipment monitoring
- Responsibilities include the coordination of all activities of the Quality Assurance Technicians and Raw Material Inspectors for all shifts of the manufacturing operation to ensure that product is manufactured and released according to customer specification and internal controls. To control and monitor product release from the incoming inspection process while ensuring compliance of the manufacturing plant with Food Drug Administration, GMP, internal procedures and corporate guidelines. To provide leadership and guidance to all areas of the Plant concerning regulatory issues that impact product, process, facility, safety and environment
- Manage Quality Assurance Technicians and Raw Material Inspectors
- Monitor and address calibration issues with equipment that impact product quality
- Provide accurate and relevant data to the management staff that can be used to continuously improve products and process
- Work as consultant with Production and Quality to address and clarify activities within the manufacturing area ensuring to follow GMP and ISO procedures.
- Perform internal and external audits
- Prepare and implement procedures, programs and validations that are requirements of the medical device manufacturing industry and regulatory agents
- Implemented a quality program that measures our assurance of adhering to procedures within the facility and to ensure preventative and corrective actions to customer complaint categories are maintained during the manufacture of our products.
- Certified Lean Six Sigma Yellow Belt and Kaizen event leader.
Production Quality Assurance Specialist:
- Review and approval of all filling master, executed batch records, stability study protocols, and validation protocols to ensure GMP, GLP and good documentation compliance.
- Assure timely initiation, classification, closure and effectiveness evaluation of production deviations and CAPA's.
- Assist with the administration of review and approval of production change control records. Ensuring proper execution of cleaning validation i.e. sample collection, release clean parts, etc for SIP and CIP processes.
- Assure the timely QA review of equipment logbooks, maintenance records, and calibration documentation.
- Review and approval of routine and non-routine work orders, calibration records, and PM's for general cleaning practice such as autoclave runs, through the Maximo System.
- Responsible for the internal audits for facility shutdown and start up while ensuring that processing equipment and manufacturing suites are prepared for GMP procedures.
- Directly involved and responsible for building a team from five QA Sample Techs for two shifts, to a group of supervisors for 5 shifts with a minimum of three QAL Sample Techs for each shift. This enabled us to support production and QAL testing labs for a process that was completed every 60 hrs. I worked within a team environment to develop quality management systems that would meet the requirements specified by CFR's, GLP's and GMP's. This was obtained through utilizing Lean Six Sigma workflow and use case scenarios to streamline our sample management procedures. This was done to ensure the best quality system possible was available to maintain the samples complete life cycle and chain of custody while pledging multiple groups with service level agreements. This project proved to be very successful in implementing our Sample Management Laboratory Information System. This and other projects were completed through utilizing my skills with lean events and Six Sigma projects
- Ensuring the development, scheduling activities and supervising three quality associates and a lab specialist.
- Review of sample management documentation submissions for In-process, validation, technical transfers, stability study and outside contract samples to ensure data processing and documentation functions comply with GLP and GMP regulations.
- Responsible for external contract lab walk through to ensure sample-handling procedures are followed to maintain sample integrity.
- As the manager, I was responsible for assembling the best interdepartmental teams for special projects that require the support of the sample management lab.
- Review of IQ, OQ and PQ's for quality equipment to ensure documentation functions comply with GLP and GMP regulations.
- Conducting weekly one on one meeting's with staff.
- Prepare and conduct semi annual and annual performance calibration reviews.
- Collaborate and communicate with the quality assurance and manufacturing groups.
- Perform non-conformance investigations.
Quality Control Analyst
- The performance of various analytical assay methods for In-Process, BDS, Stability, Validation and Process Development samples of our premier product to treat rheumatoid arthritis within a GLP environment.
- Performing the semi annual calibration and maintenance of HPLC equipment, was also a major responsibility.
- Primarily responsible for creating and maintaining the sample coordination of several validation and stability projects to ensure that all samples were submitted received and tested in a timely manner.
Senior Manufacturing Tech:
- While working for the manufacturing of clinical and commercial products, I was responsible for:
- The operation of production equipment such as, centrifuges, filtration devices, chromatography equipment, washers and autoclaves.
- Assemble and clean process equipment, and monitor processes.
- Following GMP's, complete production records and maintain clean room environment to comply with regulatory requirements.
- Investigation and writing of environmental alert/action reports
- Use and operation of Foxboro DCS Distributed Control System
- Generate and review chromatography reports through Aimdata system
- Participate in Class 100,000 clean room bulk fill bottling of various products
- Assisted in SIP Validation protocol for 200L and 500L mobile vessels
- Method development of chromatography methods for Millipore K Prime K40-II utilizing CCP Common Control Platform software version 3.00.
- I also had the opportunity to successfully develop and maintain process batch records and SOP's for various downstream process steps such as DV50 Virus filtration train and UF/DF steps.
I was responsible for performing, documenting, monitoring, and sampling procedures of protein purification involving clarification, chromatography, and concentration filtration procedures.
Manufacturing Shift Leader:
Responsibilities included performing, documenting, monitoring, and sampling procedures of protein purification involving clarification and concentration filtration procedures. I was responsible for processing techniques for ethanol and phenol fractionation purification using tubular bowl centrifugation techniques. Equipment/Instrumentation included Sharples AS16 Centrifuge, Sharples AS26 Super Centrifuge, KII Ultra Centrifuge, Helicon Ultrafiltration System, Prostak Ultrafiltration, Niro-Soavi Homogenizer, and Pharmacia Gradient Bioprocess Chromatography Skid. Validation support work.
Responsible for performing, documenting, monitoring, and sampling procedures involving filtration, purification, and lyophilization of synthetic RNA and DNA products. Procedures include depyrogenation of process equipment, buffer preparation, HIC chromatography, anion exchange chromatography, diafiltration, and lyophilization under a clean controlled environment. Responsibilities also include safe and effective cleaning verifications for product changeover and operation of production equipment Amicon K' 400, Amicon K' 40, Pall Filtron TFF Maximate System, Pall Filtron TFF Maxisette System, Virtis Genesis Lyophilizer and Freeze Mobile, Labconco Glove Box.