CSL Plasma Supv General Quality in Indianapolis, Indiana
Collaborates with Assistant Manager of Quality/Center Manager to ensure compliance with all relevant regulatory standards to ensure center is inspection ready at all times. May assume responsibility as AMQ when quality business needs are identified. This position should not be involved in manufacturing activities and must be independent from production with no additional operational responsibilities.
1 Act as lead supervisor in ensuring the day-to-day activities of quality operations are compliant with Standard Operating Procedures (SOPs) and applicable federal and local regulations as well as HR policies. Advise management of ER issues or escalated quality issues.
2 Maintain clean efficient work environment, and ensure sufficient operating supplies and forms are available. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. May conduct routine internal procedures and documentation audits. Promote safety in all actions.
3 Develop quality knowledge and assist with identifying problem areas and implement corrective action as needed with management oversight. Ensure excellent customer service by all staff.
4 Partner with quality management in collecting and analyzing data to support continuous improvement resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. Assist management in the change management process and raises ideas for consideration.
5 Coordinate and management assist with site supplier, customer and regulatory audits. Participate in the review of findings, deviation management (RCA) and written responses, as needed, to ensure a successful closure of audits. Utilize quality tools and applications to facilitate understanding of issues and documentation.
6 Partner with quality and center management so that the center is “inspection ready” at all times and customer requirements meet the safety of donors and employees including compliance with OSHA regulations. Assist with regular reports to center, area and corporate quality management regarding systems status.
7 Collaborate with management to understand and determine quality financial responsibility including budgets, forecasts and financial impact to business including quality goals.
8 Participate with management in the recruitment and selection of quality staff and in conducting performance appraisals and performance feedback.
9 Assist management with audits by working with Assistant Manager Quality Assurance and quality team to develop effective corrective action plans to address any areas of deficiency.
10 Occasionally act as back-up manager of quality in absence of Assistant Manager Quality Assurance.
11 Must successfully complete the leadership development program and be able to relocate within 12 months.
12 Maintain confidentiality of all personnel, donor and center information.
13 May be cross-trained in other areas to meet the needs of the business.
14 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.
15 Responsible for notification to the ADOQ for any event that negatively impacts the safety, quality, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following: Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance.
16 Perform other duties, as assigned, to support business needs.
• Bachelor's degree preferred
• Equivalent combination of education and professional work experience required
• BS/AS degree OR
• Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others OR
• 1 year Quality/L&D experience required
• Maintain company Technical Training certification
• Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations
• Proficient in English
(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 required to work with the public when they are dissatisfied
• 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.
• Required to wear Personal Protective Equipment while performing specific tasks or in certain areas
• Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc.
• Frequently required to make and accept modifications to working processes and procedures as directed by SOP
• Overnight travel required up to 10% of the time
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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