CSL Behring Columbia , SC 29209
This position should not routinely be involved in manufacturing activities and must be independent from production with no additional operational responsibilities. Responsible for establishing and implementing an effective Quality Assurance system. Managing the realization of Good Manufacturing Practices (GMP) performance at the assigned Center business. This position is responsible for supporting Assistant Quality Manager in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal international regulatory requirements.
Assist with the reporting of compliance status to operational and quality management
Participate with center management in the development and implementation of continuous improvement plans
In the absence of the Assistant Quality Manager (AQM), represent the center during internal and external audits, respond to questions and may stop operations, including shipments to address quality concerns
1 Perform final QA review and release for all shipments and associated documents, to ensure shipment meets customer specifications.
2 Ensure center is "inspection ready" at all times by conducting daily, weekly, monthly, bi-annual and annual compliance checklist for the systematic monitoring of center quality compliance status. Document findings, develop and implement corrective actions.
3 Performs center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.
4 Review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements.
5 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management.
6 Assist the AQM with the quality team in identifying and communicating non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meetings to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation at the center.
7 Assist the AQM with review of Safety, Health and Environment Polices & Procedures. Ensure safety training and safety practices are implemented and followed within the center.
8 Assist in conducting internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OSHA, FDA and other regulations, as applicable and develop center response for deficiencies.
9 In the absence of the AQM, host external audits conducted by regulatory agencies and customers.
10 Initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented and effective.
11 Assist Plasma center staff in completing other special projects or assignments, as requested.
12 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedures and documentation audits, as applicable. Promote safety in all actions.
13 Follow all Standard Operating Procedures (SOPs), company policies and procedures.
14 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.
15 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.
16 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.
17 Perform other quality duties, as assigned, to support business needs.
High school diploma or equivalency required
Associate's Degree or equivalent combination of education and professional work experience preferred
Experience in regulated environment strongly preferred
Understand Quality Systems and/or regulated training requirements
Learn new processes and quickly engage in assignments to drive for action
Attention to detail and ability to follow written and verbal directions in exact detail required
Frequently required to make and accept modifications to working processes & procedures per SOP
Lead teams without the benefit of a direct reporting relationship
Make decisions in accordance with established policies and procedures
Exercise independent and good judgment to refer decisions when decisions fall out of the realm of established guidelines
(physical & mental requirements)
Shares information with internal contacts with common desire to reach a solution
Ability to make decisions, which have moderate impact on immediate work unit.
Must be able to see and speak with customers and observe equipment operation.
Occasionally perform tasks while standing and walking up to 80% of time
Reach, bend, kneel and have high level of manual dexterity
Occasionally be required to lift and carry up to 25 pounds
Fast paced environment with frequent interruptions
Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens
Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc.
Required to wear Personal Protective Equipment while performing specific tasks or in certain areas
Required to work overtime and extended hours to support center operational needs
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.
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