This position will be responsible for reviewing finished product, semi-finished product, and compounding Batch Records for all products manufactured and/or packaged at the Waco facility ensuring compliance with Standard Operation Procedures and current Good Manufacturing Practices. This position is responsible for performing the Quality Assurance review of product records to support the final disposition process in Waco and coordinating training within the department. Responsible for the issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments at the Waco facility with compliance to site Standard Operating Procedures and current Good Manufacturing Practices.
This position is responsible for the following:
- Real time Review and approval of records by QA on the shop floor. These records include but not limited to finished product, semi-finished product, and compounding Batch Records.
- Understand cGMPs and procedural requirements for your area of responsibility and be a resource to operators and other personnel to ensure compliance to these requirements.
- Make decisions consistent with job responsibilities, regulations, procedures and policies. Provide appropriate comments to cGMPs documents, when needed. Provide timely feedback and details to supervision and other impacted personnel.
- Work together with Operations on resolving quality events on time.
- Provide approval for re-work and in-process retest forms as well as any other supporting document that requires Quality signature.
- As part of the batch review process perform continuous Gemba walks in the operation area.
- Complete and conform to all training requirements for job role, including company-required and job role-specific training.
- Carry out and assist in the on-going training of new and existing personnel, as appropriate.
- Assess and understand events that may not be in accordance with procedures or cGMPs. Make decisions consistent with job.
- Empowered to make Quality decisions.
- Be part of Operation area T-2 meetings.
- Participate and support OPEX initiatives and seek process innovation and continuous process improvement.
- Reviews documents and collaborates with Production to identify defects and manufacturing trends.
- Actively provides input and suggestions to help analyze and resolve Production problems.
- Prepares required documentation regarding batch disposition to international sites as required.
- Identifies and brings to resolution all batch record discrepancies to prevent a regulatory impact.
- Performing the Quality Assurance Issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments.
- Issue batch records to support manufacturing and Production for the Waco facility ensuring accuracy, compliance, adherence to Data Integrity, and current Good Manufacturing Practices.
- Issue PSO, Clinical Studies, Demonstration, and Validation Batch Records for Production use.
- Assist Documentation Department to prepare, assign, and issue logbooks for the Waco facility.
- Perform other duties as assigned
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS)
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Education and Experience:
High School Diploma or GED Equivalent. Associates Degree preferred or bachelor’s degree in the Sciences or Technical field preferred.
Three (3) years of experience in handling and reviewing documentation records.
One (1) year of both Microsoft Word and Microsoft Excel experience. SAP experience preferred.
Three (3) years of experience in a CGMP Environment
Prefer experience in an aseptic manufacturing environment
Essential Knowledge, Skills & Abilities:
- Excellent analytical and problem-solving skills, detail oriented.
- Excellent organizational skills. Ability to manage multiple tasks.
- Working knowledge of Quality Assurance systems, cGMP’s, ISO 13485, CMDRs, and EMEA regulations.
- Detail-oriented and self-motivated
- Excellent hand-eye coordination and manual dexterity.
- Excellent math skills; ability to add, subtract, multiply, and divide.
- Ability to read, comprehend, write, and communicate effectively in English.
- Ability to carry out detailed written or oral instructions.
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
- Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
- Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
Significant Work Activities: N/A
Job Type: Experienced