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Compliance Manager, Laboratory Services

Company: BioBridge Global
Location: El Paso
Posted on: February 14, 2019

Job Description:

, a subsidiary of Employer, is one of the largest independent non-profit testing laboratories in the United States for blood and plasma products. QualTex Laboratories is dedicated to supporting global public safety with the timely delivery of high-quality testing services for patients, donors and regulated biological products.General SummaryResponsible to manage critical systems for QualTex Laboratories. Will facilitate organizational excellence throughout all departments, exhibit leadership, and maintain extensive knowledge of regulatory/quality requirements. Maintain knowledge of all current Standard Operating Procedures (SOPs) required to perform effectively. Maintain excellent communication with all personnel.Commit to and abide by the character of Employer s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.Provide world class customer service by capturing and being responsive to the voice of the customer (including donors) through established feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.Must have a valid driver's license and be at least 21 years old with a good driving record to meet organization driving standards.Major Duties and ResponsibilitiesEssential TasksDevelop, manage, and oversee designated activities for QualTex Laboratories.

  • Monitor assay and process performance by gathering, collating, analyzing data, and producing statistical reports
  • Perform and facilitate root-cause analysis, utilizing industry recognized quality tools, for Quality Improvement Reports, Customer Complaints, negative trending assay and process performance reports, failed Proficiency Testing, and internal and external audit nonconformities.
  • Initiate and facilitate process improvement projects which ensure the organization s ability to remain regulatory compliant.
  • Develop, draft, revise SOPs, training documents, validation/verification plans, test cases, validation/verification summaries and review completed validations.
  • Proactively perform effectiveness checks and production audits. Assist with internal and external audits as directed.Maintain strict adherence to SOPs, regulatory requirements, and all company policies.Competently perform all assigned departmental duties.Assist with Quality training and/or mentoring new employees.Interview and make recommendations in regards to hiring, terminating, promoting, demoting, evaluating, counseling, and salary changes for departmental personnel as needed.Develop, initiate, and lead team-oriented work projects for the development and implementation of strategic initiatives, validations, process improvements, and Standard Operating Procedures (SOPs).Demonstrate utilization of performance excellence principles by:
    • Using data and facts to plan and make decisions.
    • Ensuring that organizational goals/strategic objectives are converted to appropriate actions to align work.
    • Measuring and monitoring progress toward achieving the organization s goals/strategic objectives.
    • Display positive leadership skills and champion strategic and management directives with department employees by committing to and embracing the mission, vision, and core values of QualTex Laboratories:
    • Be dedicated to the highest standards of quality and adhere to all safety, regulatory, and quality requirements.
    • Foster an atmosphere of open, honest communication and knowledge sharing among workers in business units throughout the organization.
    • Demonstrate respect for co-workers and management
    • Consistently improve performance outcomes in customer satisfaction, worker engagement (motivation and satisfaction), operational excellence, innovation, and financial performance.Maintain a positive work attitude and participate in self-improvement as an effective leader.Maintain a professional demeanor at all times while representing QualTex Laboratories.Participate in continuing education and attend meetings as required. Maintain excellent communication with management.Maintain a close working relationship with all other support departments.Serve as the Quality Liaison between Operations and the Quality Assurance department.Performs other duties as assigned.Non-Essential TasksAssist in other laboratory areas as needed.EducationRequires a Bachelor s Degree from an accredited college or university with major course work relative to the field of assignment. Required major is Applied Science or equivalent.Prefer a Master's Degree from an accredited college or university.Licenses and/or CertificationsTexas Operators Driver s LicenseUS Passport preferredCategorical Certifications preferredMedical Technologist (MT)(CLS)/MLT or equivalent preferredAmerican Society for Quality Certifications preferredExperienceRequires five or more years of job specific experience.Prefer supervisory experience.KnowledgeMust maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies. Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc. Must recognize, resolve, and facilitate resolution of deviations encountered in all phases of work.Must acquire a working knowledge of quality and laboratory systems.SkillsMust have strong computer skills.Must maintain competency in laboratory skills for liquid and material handling.Must demonstrate positive leadership skills.Must have excellent written and oral communication skills.Must be capable of operating motor vehicles in all types of weather conditions.Must be capable of performing, evaluating, and reporting on laboratory systems.Must be capable of deploying quality tools and facilitating quality improvements.AbilitiesMust be able to correctly interpret process outcomes.Must be able to keep information confidential.Must be able to work with interruptions, meet deadlines, and perform accurate work and/or reports. Must be neat in appearance and well groomed.Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.Must perform well in a repetitive work environment and meet deadlines.Must work well independently and as a team member as well as facilitate organizational team activities.Working EnvironmentWorks in a well-lighted air conditioned and heated laboratory/department. Laboratory consists of complex setting with robotic instrumentation. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face. Will work extended hours during peak periods. May be required to work any time of the day, evening or night during the week or weekend to include being on-call. May be required to use personal motor vehicle on company business. May be required to participate in national and/or international travel.Physical RequirementsMust be able to drive on behalf of the organization.Requires manual and finger dexterity and eye-hand coordination.Will require walking, bending, and prolonged sitting and/or standing during work hours.Required to carry up to 25 lbs. and occasionally lift up to 40 lbs.Requires normal or corrected vision and hearing corrected to a normal range.All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include: Competitive salary 100% Employer Paid Life Insurance Variable Compensation Plan 100% Employer Paid Long-term Disability Plan Paid Time Off (PTO) 100% Employer Paid AD&D Extended Illness Benefits (EIB) 100% Employer Paid Employee Assistance Program Shift Differentials Group Health Medical Plan w/prescription coverage Paid Holidays Variety of Voluntary Supplemental Insurances Leaves of Absence Voluntary Dental Coverage Educational Assistance Program Voluntary Vision Professional Development Plan (PDP) Flexible Benefit Cafeteria Plan Credit Union Tax Deferred Retirement Plan 401kQualTex Laboratories, a subsidiary of Employer, is proud to be an Equal Opportunity Employer committed to providing employment opportunities to minorities, females, veterans, and disabled individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, genetic data, sexual orientation, gender identity, or any other legally protected characteristics. For more information about your EEO rights as an applicant under the law, please click. QualTex Laboratories maintains a Tobacco & Drug-Free Workplace.

      Keywords: BioBridge Global, El Paso , Compliance Manager, Laboratory Services, Executive , El Paso, Texas

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