Assistant manager of quality job description

• You will report to the Associate Director, Quality
• Ensure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system.
• Manage the Quality Control program, calibrations management, monitor of compliance to defined processes e.g. sampling, competency checks, trending and analysis of Indicators, cause and failure mode impact assessment and change management.
• You will recruit, hire, conduct performance reviews, lead investigations and deviations, enact corrective actions, and termination.
• Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA), federal, state and local regulatory, company procedures.
• Follow all HR practices through fair treatment of all employees.
• Monitor CAPA's and effectiveness checks to ensure issues are resolved.
• Overnight travel required up to 10% of the time.

Education

• Bachelor's degree in scientific discipline/life sciences or related discipline preferred OR equivalent combination of education and professional work experience required

Experience

• 5+ years' experience related to quality and regulatory/ Plasma industry experience
• 1 year supervisory, leadership experience responsible for overseeing the activities of others
• 1year Quality experience (CSA/CSAb) required
• Completion of CSL Plasma Leadership Development program

Additional Comments

• Maintain company Technical Training certification
• Knowledge of complex government and industry regulations, and ability to monitor compliance with these regulations
• Manage entire financial responsibility of the center
• Proficient in English

Working Conditions

• Exposure to hazardous chemicals, extreme temperatures and to bloodborne pathogens.
• Required to wear Personal Protective Equipment while performing tasks or in certain areas

Benefits

CSL offers the following benefits: medical/dental/vision benefits, Short- and Long-term disability, tuition assistance, 401K, 15 days of PTO, 4 personal holidays + 8 company holidays/year.

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 classification.

#CB

Company DescriptionSupported by parent company CSL Behring, the global leader in plasma protein biotherapeutics, CSL Plasma has more than 300 plasma collection centers globally. CSL Plasma also has a state-of-the-art testing laboratory that features some of the most advanced technology, instrumentation and automation in the field; two logistics centers, one in Dallas and one in Indianapolis. Our corporate headquarters is in Boca Raton, Florida.

Our U.S. plasma collection centers are committed to the highest standards of quality and safety. When you donate, you give a valuable gift to those who require plasma-derived therapies to live healthier lives.

The CSL Group has a combined heritage of outstanding contribution to medicine and human health with more than 100 years’ experience in the development and manufacture of vaccines and plasma protein biotherapies.

With major facilities in Australia, Germany, Switzerland and the US, CSL has over 30,000 employees working in 100 countries.

Nippon Express Company, Ltd. ("NX") was founded in 1872 in Japan and is headquartered in Tokyo. NX employs approximately 72,000 employees at 733 locations, in 47 countries and 314 cities around the world.

Nippon Express U.S.A., Inc. ("NEU") was incorporated in New York in 1962 as a fully owned subsidiary of NX. NEU provides logistics solutions and comprehensive transportation services through its international freight forwarding and logistics network, including specialized handling of: air, land, sea and express packages; all types and sizes of cargo; personal effects and household goods; fragile and perishable freight; and livestock. NEU also provides related services, such as warehousing, distribution and customs brokerage and clearance. NEU operates at 55 locations in 27 states within the U.S., with approximately 1300 employees. NEU has enjoyed tremendous growth and success as one of the top five international freight forwarders in the world. We connect people with products throughout the world.
Purpose:

The Main Purpose of this position includes:

+ Responsible for implementing and supporting maintenance of the Quality Management System within the region, serving as a liaison for Quality & Compliance Management Team (Q-CMT) through administration of policies and procedures and escalating data, concerns and improvements to Station Management.

+ Ensuring closure and documentation of all Audits conducted, including issuance and completion of all Nonconformance Reports (Corrective Actions, Action Items, etc.)

+ Monitoring, Data Analysis and Reporting on quality and compliance-related activities and systems for communication to members of the Region, Q-CMT, CMD and other regulatory oversight committees (i.e. ECCT, etc.).

Note: As a Quality representative in a region, this position will have dual (dotted-line) reporting relationships to designated Regional management and to the Director of Compliance Management Division (CMD).

Essential Duties:

Auditing

+ Providing input into Design and Content of Internal Audits

+ Participate in Internal Audit Program

+ Prepare stations for and participate in External Audits

+ Ensure local audit schedules are prepared, posted and are being carried out.

+ Close Audits, Issue Nonconformance Reports (Corrective Actions, Action Items, etc.) and provide regional analysis and reporting on audit results.

Quality Compliance

+ Monitor & Compile Data for Analysis related to Quality System KPI results and Quality Management System compliance at routine intervals to ensure suitability and effectiveness of Quality System Compliance and related Database/System usage

+ Ensure corrective actions are addressed and closed in a timely manner and contain documented verification of effectiveness or are escalated accordingly.

+ Update Access control levels of staff

+ Provide input into and editing of Policies, Procedures and other related materials.

Training

+ Monitor regional compliance with regulatory and training requirements and assist in coordination of training events and data

+ Develop Training Materials and provide training/seminars in key areas of Quality Management System knowledge, as needed.

Regulatory / Security

+ Monitor compliance with related regulatory and security areas, including TSA, CCSF, Export Administration Regulations, TAPA, C-TPAT, DOT and Facility security.

Safety

+ Review safety processes to ensure compliance with OSHA and other agencies and meeting NEUS safety expecations.

+ Create and update safety protocols as needed and provide training

Reporting

+ Escalating data, concerns, and improvements to Station Management to promote awareness and improvement of Quality Management System.

+ Collect and compile data for analysis and presentation at related Regional, Divisional and Committee meetings.

+ Communicate announcements via email and regional Notices to Regional staff

+ Provide follow-up reporting to Registrars, Auditors and CMD as necessary.

+ Provide Expense reports in accordance with travel and purchasing requirements.

+ Support addressing of issues related to violations, mitigations or other disclosures, as required.

Minimum Requirements:

+ Associates, Bachelors or Equivalent/Related Industry experience

+ Advanced Knowledge of MS Office Products, including Outlook, Word, Excel, PowerPoint and SharePoint

+ Strong organization and communication skills

+ Capability to schedule, organize and work independently.

+ Knowledge of Compliance and Performance Standards (ISO 9001, AS9120, etc.)

+ Knowledge of Regulatory & Industry Standards

+ Strong Teamwork skills

+ Some Regional Travel, as required.

Organization Relationships:

Reports To:

+ Assistant General Manager of branch warehouse

Work Environment:

(With or without accommodations) This position is predominantly sedentary office work, which involves sitting, typing, filing, and conversing on the phone. Walking and standing in warehouse enviroment.

This job description is not intended to be and should not be construed as an all-inclusive list of all the responsibilities and working conditions of the position. While it is intended to accurately reflect the position activities and requirements, management reserves the right to modify, add or remove duties and assign other duties as necessary.

Nippon Express offers a generous Employee Benefits Package including:

+ Medical, Dental, and Vision beginning the 1st of the month after 30 days.

+ 401k with a company match

+ Flexible Spending Accounts, HSA, Life and Accidental Death & Dismemberment Insurance, Short & Long Term Disability, Auto and Home policies, Commuter Benefits, and much more.

+ Generous Vacation and Sick time.

Nippon Express USA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.


External Company URL: nipponexpressusa.com

Post End Date: 11/30/2022