Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Mgr Asst Quality Assurance

Expired Job

CSL Behring Columbia , SC 29209

Posted 3 months ago

This position should not routinely be involved in manufacturing activities and must be independent from production with no additional operational responsibilities. Responsible for establishing and implementing an effective Quality Assurance system. Managing the realization of Good Manufacturing Practices (GMP) performance at the assigned Center business. This position is responsible for supporting Assistant Quality Manager in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal international regulatory requirements.

  • Assist with the reporting of compliance status to operational and quality management

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

  • In the absence of the Assistant Quality Manager (AQM), represent the center during internal and external audits, respond to questions and may stop operations, including shipments to address quality concerns
    1 Perform final QA review and release for all shipments and associated documents, to ensure shipment meets customer specifications.
    2 Ensure center is "inspection ready" at all times by conducting daily, weekly, monthly, bi-annual and annual compliance checklist for the systematic monitoring of center quality compliance status. Document findings, develop and implement corrective actions.
    3 Performs 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 Review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements.
    5 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.
    6 Assist the AQM with the quality team in identifying and communicating non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meetings to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation at the center.
    7 Assist the AQM with review of Safety, Health and Environment Polices & Procedures. Ensure safety training and safety practices are implemented and followed within the center.
    8 Assist in conducting internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OSHA, FDA and other regulations, as applicable and develop center response for deficiencies.
    9 In the absence of the AQM, host external audits conducted by regulatory agencies and customers.
    10 Initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented and effective.
    11 Assist Plasma center staff in completing other special projects or assignments, as requested.
    12 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 procedures and documentation audits, as applicable. Promote safety in all actions.
    13 Follow all Standard Operating Procedures (SOPs), company policies and procedures.
    14 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.
    15 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.
    16 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.
    17 Perform other quality duties, as assigned, to support business needs.


  • High school diploma or equivalency required

  • Associate's Degree or equivalent combination of education and professional work experience preferred


  • Experience in regulated environment strongly preferred

  • Understand Quality Systems and/or regulated training requirements

  • Learn new processes and quickly engage in assignments to drive for action

  • Attention to detail and ability to follow written and verbal directions in exact detail required

  • Frequently required to make and accept modifications to working processes & procedures per SOP

  • Lead teams without the benefit of a direct reporting relationship

  • Make decisions in accordance with established policies and procedures

  • Exercise independent and good judgment to refer decisions when decisions fall out of the realm of established guidelines

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 perform tasks while standing and walking up to 80% of time

  • 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

  • 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

  • Required to work overtime and extended hours to support center operational needs

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.

Worker Type:


Worker Sub Type:


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

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
Analyst Senior Quality Assurance

Bluecross Blueshield Of South Carolina

Posted 5 days ago

VIEW JOBS 11/14/2018 12:00:00 AM 2019-02-12T00:00 Summary Performs quality control audits to evaluate accuracy and effectiveness of departmental operations functions including, but not limited to, claims, membership, customer service/call center, workflow, processing support systems, procedures, documentation, etc. Identifies problems, analyzes cause and effect, and makes recommendations for improvements. Description * 35% Conducts focused quality audits across various operations functions to ensure quality standards, procedures, and methodologies are being followed. Documents findings of analysis and prepares recommendations for implantation of new systems, procedures, or organizational changes to reduce errors. * 35% Identifies areas of weakness and communicates recommendations on changes and improvements to training materials. Provides feedback to management on errors detected, ensures errors are resolved, and provides long-range solutions to causes. Develops and implements a quality control and improvement program based on targets identified through the quality reviews. Monitors and evaluates the implementation of corrective action plans. * 20% Compiles data, provides feedback, and generates reports for operations and/or training areas on quality performance. Trains new employees and remains current with all guideline changes, work instructions, etc. Writes or assists in writing desk procedures and training materials for departments. * 10% Provides assistance with special projects such as testing for new business implementation or system changes, reviewing change requests, interpreting department workload, statistical reports, assisting co-workers, etc. Required Work Experience: * One year of related claims processing, customer service, auditing, training, analysis or operations experience. * Two years of experience performing quality audits. Required Education: * High School Diploma or equivalent Skills and Abilities: * Conducts audits * Prepares summary reports * Demonstrates strong proficiency in math * Maintains quality improvement process * Writes reports of audit findings Preferred: * Experience with document writing, documentation control, and managing multiple documentation development assignments. * Experience with Doc1 Designer, instructional writing, and web content manager (WCM) a plus. We participate in E-Verify and comply with the Pay Transparency Nondiscrimination Provision. We are an Equal Opportunity Employer. Equal Employment Opportunity Statement BlueCross BlueShield of South Carolina and our subsidiary companies maintain a continuing policy of nondiscrimination in employment to promote employment opportunities for persons regardless of age, race, color, national origin, sex, religion, veteran status, disability, weight, sexual orientation, gender identity, genetic information or any other legally protected status. Additionally, as a federal contractor, the company maintains Affirmative Action programs to promote employment opportunities for minorities, females, disabled individuals and veterans. It is our policy to provide equal opportunities in all phases of the employment process and to comply with applicable federal, state and local laws and regulations. We are committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please e-mail or call 1-800-288-2227, ext. 43172 with the nature of your request. We will make a determination regarding your request for reasonable accommodation on a case-by-case basis. Bluecross Blueshield Of South Carolina Columbia SC

Mgr Asst Quality Assurance

Expired Job

CSL Behring