Quality Specialist (Bilingual - English/Spanish)

CSL Behring National City , CA 91950

Posted 2 months ago

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

  • Reporting compliance status data to operational quality management

  • Collaborate with center management in the development and implementation of continuous improvement plans

  • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns

  • Responsible for coordinating and managing training activities, policies and processes at the center level

1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.

2 Ensure 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.

3 Perform 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 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements.

5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.

6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used

7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues.

8 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.

9 Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation.

10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.

11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers.

12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective.

13 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 procedure and documentation audits, as applicable.

14 Follow all Standard Operating Procedures (SOPs), company policies and procedures.

15 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.

16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.

17 Assist Plasma center staff in completing other special projects or assignments, as requested.

18 Perform other job-related duties, as assigned.

Education

  • High school diploma or equivalent required. Associate or Bachelor's degree in business administration or biological sciences preferred.

Experience

  • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment.

  • Strong customer service skills

  • Strong critical reasoning, decision-making and problem solving skills to analyze situations

  • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives

  • Understand Quality Systems and/or regulated training requirements

Working Conditions

(physical & mental requirements)

  • Occasionally required to work with the public when they are dissatisfied

  • 80% of the time standing and walking and 20% of the time sitting

  • Reach, bend, kneel and have high level of manual dexterity

  • See and speak with customers and observe equipment operation

  • Occasionally be required to lift and carry 25 lbs.

  • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

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.

#CB

Worker Type:

Employee

Worker Sub Type:

Regular


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Central Operations Specialist

Seacoast Commerce Bank

Posted 6 days ago

VIEW JOBS 3/27/2020 12:00:00 AM 2020-06-25T00:00 Seacoast Commerce Bank is a Community Bank headquartered in San Diego, California. We have offices located throughout the United States. We are looking for an exceptional candidate to become the newest member of the Seacoast team! We are seeking a Central Operations Specialist to provide back office operational support for all bank branches. Essential Duties and Responsibilities * Ensure that the highest standard of customer service is provided to all customers and work with branch staff to resolve any issues or account problems. * Perform routine duties related to adjustments, cashier checks, levies, chargebacks, interest checks, cash orders and shipments, remote deposit capture, legal process handling, non-posted items, NSF and returned items, foreign items and verification of deposits. * Audit new accounts and verify information is correct, meets regulatory guidelines and is in alignment with bank policies and procedures. Review new account processes for best practices on a recurring basis. * Verify new account documents are completed correctly. Continually review document archival process for best practices. * Maintain and utilize current knowledge on all regulations pertaining to the Central Operations Department including FDIC insurance, account vesting, EFT limits, Reg CC, Rag D, Red E, BSA/Patriot Act, Privacy, UCC4A, NACHA and dormant accounts. * Provide Online Banking, ACH and debit card telephone support to internal and external customers. * Support wire transfer operations. * Process Fedline activity to include wires, ACH transactions (returns and NOCs), Cash deposits and ordered, check adjustments, and collection items. * ATM settlement and transaction reconcilement. Process Reg E claims, monitor and report suspicious card activity. * Perform all Reg D monitoring for excessive activity, including customer notification * Establish new PC banking clients on the Net Teller system and provide customer support. * Understand procedures to be followed in the case of robbery or other emergency. * Demonstrate a satisfactory understanding of and adherence to Bank operational policies and applicable compliance regulations as they relate to the specific job duties assigned. * Demonstrate a satisfactory understanding of your duties and responsibilities as it relates to the Bank Secrecy Act (BSA), Anti-Money Laundering Act (AML), Patriot Act, and Office of Foreign Assets Control Regulations (OFAC). This includes participating in any required training and promptly complying with all reporting requirements. Job Requirements The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * High School diploma or equivalent. * 2 years of relevant bank operations and new accounts experience. * Must be proficient in the use of FedLine Advantage. * Excellent written and verbal communication skills. * Excellent organizational skills. * Ability to perform detail oriented work with a high degree of accuracy. * Ability to handle multiple priorities and tasks while working in a fast paced environment. * Proficiency with personal computers and related software. Salary/Benefits We offer a competitive package of compensation and benefits, including: Medical, Dental & Vision Insurance Life Insurance Long Term Disability Insurance Short Term Disability Insurance Long Term Care Insurance Employee Assistance Program Employee Stock Purchase Plan 401(K) plan with generous employer match Flexible Spending accounts Paid vacation & holidays Seacoast Commerce Bank is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Seacoast Commerce Bank National City CA

Quality Specialist (Bilingual - English/Spanish)

CSL Behring