CSL Plasma Supervisor General Quality in Fort Wayne, Indiana

Supervisor General QualityUnited States of AmericaR-0760992015 CSL Plasma

Job Description

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.

Education

• Bachelor's degree preferred

• Equivalent combination of education and professional work experience required

Experience

• 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

Working Conditions

(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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State/ProvinceIndiana

CityFort Wayne

Street Address108 East Pettit Avenue

Primary LocationCSL Plasma US-Ft Wayne 089

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.

https://www.cslbehring.com/careers/eeo-statement