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Quality Specialist

Employer
CSL
Location
Pinellas Park, FL
Start date
May 23, 2024

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Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

Responsibilities: Mgr Center • Has overall authority for center operations production goals, monitor net yields, and implement improvement plans as required. Meet daily, weekly and monthly deadlines and maintain operational records. • Manage all inventories to the optimum levels by maximizing efficiencies, customer service levels and minimizing investment. Support meeting daily, weekly and monthly deadlines and maintain Center’s operational records. • Monitor donor retention, ensure efficient donor flow, and implement donor retention improvement and corrective action plans, as required. • Ensure compliance with all Company SOPs and applicable federal, state and local regulations. Perform nearly all staff tasks and duties at a proficiency level adequate for training and critiquing employees in the performance of those tasks and duties. • Responsible for all aspects of financial oversight to include: setting annual budget, ensuring center meets monthly financial targets and on-going cash management objectives, and adhering to cash management, financial reporting and other financial responsibilities. • Responsible for overall center quality compliance by ensuring the business is inspection ready at all times and meetings with QA to include but not limited to regulatory and customer requirements to ensure the purity and efficacy of the plasma and the safety of donors and employees. Communicate any quality concerns or issues to Associate Director of Operations and Quality. • Develop and foster a center philosophy continuous improvement and support company values. Collect and analyzes data to maintain and improve center quality, efficiency and profitability. Implement effective correction action plans when appropriate. • Collaborate with quality to ensure center complies with company, regulatory and customer requirements to safeguard the purity and efficacy of the plasma and the safety of donors and employees. • Participate during all audits with quality personnel and Quality team to develop effective corrective action plans to address any areas of deficiency noted during audits. • Follow all HSE and OSHA policies and procedures. Ensures the center and all employees comply with OSHA regulations and training. Complete all OSHA record keeping and reporting requirements. • Maintain clean efficient work environment, and ensure sufficient operating supplies and forms are available as needed. May conduct routine internal procedures and documentation audits. • Support facility maintenance to highest safety, compliance and cleanliness standards. Partner with corporate facilities to ensure center compliance at all times. • Conduct recruitment, training, development, counseling and termination. Manage effectively employee turnover within center operations. Adhere to HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure compliance. • Ensure excellent customer service by all staff. Provide a model of good customer service to employees. Communicate openly with customers. Effectively resolve complaints or concerns. • Monitor all marketing and advertising to ensure effectively executing programs for desired results. Make applicable recommendations to improve effectiveness. • Represent the Company and center in the community and with other business, local publications and vendors. • Maintain confidentiality of all personnel, donor and center information. • Perform other duties, as assigned, to support business needs. Education • Bachelor’s Degree preferred • Equivalent combination of education and professional work experience (4 years minimum) required Experience • Minimum 2 years supervisory or leadership experience responsible for overseeing the activities of others required OR • Completion of CSL Plasma Leadership Development program Additional Comments • Maintain company Technical Training certification • Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations • Monitor and manage entire financial responsibility of the center • Proficient in English Working Conditions (physical & mental requirements) • Ability to make decisions which have significant impact on the department’s creditability, operations and services • Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations • Reach, bend, kneel and have high level of manual dexterity to lift boxes, carry instruments, pull or push furniture and/or supplies • Overnight travel required up to 10% of the time • Occasionally lift and carry up to 25 lbs. • Occasionally perform tasks while standing and walking up to 100% of the time • See, hear and speak with customers and observe equipment operation • Frequently required to make and accept modifications to working processes and procedures as directed by SOP • Exposure 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 • Fast paced environment with frequent interruptions 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. Mgr Field Support • Train and collaborate with Center Manager (CM) and/or have overall authority to assigned center’s operations production goals, monitor net yields, and implement improvement plans as required. Meet daily, weekly and monthly deadlines and maintain records as required by operations, business, etc. • Responsible for all aspects of financial oversight, while assigned a specific location to include: ensuring center meets monthly financial targets and on-going expense management, financial reporting and other financial responsibilities. • Ensure excellent customer service in centers. Provides a good customer service model to employees, communicates openly with customers, ensures efficient donor flow and processing times and effectively resolves complaints or concerns in a timely manner. • Support facility maintenance to highest safety, compliance and cleanliness standards. Partner with corporate facilities to ensure center compliance at all times. • Train and collaborate with the Assistant Manager of Quality (AMQ) and/or to have overall authority to assigned center’s “inspection readiness” at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. • Assure center reports are prepared regularly for area and corporate quality management to provide confirmation of the state of quality and systems at the center meet expectations. • Identify and review quality and safety risk for assigned centers and work with center and remote leadership to develop appropriate actions. • Provide support during audits with quality personnel to develop effective corrective action plans to address any areas of deficiency noted during audits. • Provide oversight of employee relations issues in collaboration with center ADOQ/RD, train, and collaborate with center and remote leadership to do so. This includes but is not limited to decisions for hiring, firing, corrective actions and salary structures. Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance. Develop center leadership team through hiring, training, coaching and effective succession planning. • Follow all HSE and OSHA policies and procedures. Ensures the center and all employees comply with OSHA regulations and training. Complete all OSHA record keeping and reporting requirements. • Perform other job-related duties as assigned. Mgr New Center Support • Identifies new center training team resources. Develops training plans and ensures that all designated trainers maintain current training certifications. • Monitors training effectiveness by ensuring training completion rates meet established targets. Conducts onsite visits as necessary. Identifies and implements training improvements as needed. • Schedule assignments of New Center Training team. Allocates resources as needed. • Responsible for financial oversight of training team travel costs, ensuring team meets financial targets and responsibilities. • Develops training team budget. • Provide oversight of training team employee relations issues. This includes, but is not limited to, hiring, firing and corrective actions. • Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicates effectively with HR to ensure HR compliance. • Provides support and guidance to Assistant Manager, New Center Support by effective training and coaching. • Ensure that the new center Designated Trainers are effectively delivering process knowledge to all staff members. Monitors progress of multiple trainings occurring simultaneously at varying stages of completion. • Coordinate with multiple new center leadership teams to evaluate training team performance. • Ensure effective communication between new center leadership, Assistant Manager New Center Support, Designated Trainers and Trainees during the training process. Provides status updates to new center leadership team on trainees performance and training progress. • Uses Adult Learning Styles to coach Assistant Manager, New Center Support on challenging training situations. Collaborates with AD, OBD and/or L&D as needed. Other job-related duties as assigned. Qualifications: • Bachelor’s degree or equivalent combination of education and relevant work experience (4 years minimum) required • 2+ years' supervisory or leadership experience or • Completion of CSL Plasma Leadership Development program • Company Technical Training Certification • Knowledge of continuous improvement concepts Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Our Benefits

CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.

About CSLPlasma

CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Plasma!

Company

CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people.

Areas of Expertise

We focus and demonstrate global leadership in three distinct areas—rare and serious diseases; influenza vaccines; and iron deficiency and nephrology.

Rare & Serious Diseases

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Vaccines

As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries.

Iron Deficiency & Nephrology

With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women’s health, we help patients affected by these conditions to live better, healthier lives.

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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