Senior Specialist, Quality Assurance

in Dallas, TX

Senior Specialist, Quality Assurance Job

Job Description Job Attributes+

  • Job ID

    cbcc48c3-7d48-4433-885a-ce995dd5d95c

  • Req #

    20085909

  • Job Location

    7920 Elmbrook Dr
    Dallas, TX 75247, US

  • Job Category

    Quality

  • Job Type

    Regular

  • Schedule

    Full time

Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

The primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

What Quality Assurance contributes to Cardinal Health

Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective.Demonstrates knowledge of quality systems and approaches.Demonstrates an understanding of the relevant regulations, standards and operating procedures.Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

Schedule

40 hours per week. Monday-Friday 8-hour shifts, 1:00am-9:00am or 4:00am-12:00pm. Hours may vary 1-2 hours depending on need. Working one Saturday, every other month. Candidate must be flexible to work different shifts or schedules based on business need.

Accountabilities

Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM.Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities.Engages and collaborates with operations department to drive quality system and CGMP requirements.Performs product release activities per CGMP requirements.Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification.

Qualifications

Bachelor’s degree in related science field, or equivalent work experience (Microbiology, Chemistry, Biology, Physics) preferred2+ years of experience in related science field preferred1-2 years of experience in Quality Assurance and/or regulated environment highly preferred – cGMPPharmaceutical or medical device experience a plusEffective written and verbal English communication skills ISO experience a plusAbility to lift between 50-75 lbs

What is expected of you and others at this level

Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasksWorks on projects of moderate scope and complexityIdentifies possible solutions to a variety of technical problems and takes actions to resolveApplies judgment within defined parametersReceives general guidance may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracyAbility to manage several tasks at the same time; Ability to focus on tasks; Ability to evaluate operating conditionsAbility to exercise sound judgment Personal Protective Equipment

Your safety is our top priority. We regularly consult with medical professionals on best practices in COVID-19 prevention to protect our employees. We train our employees on these best practices and regularly clean our sites in accordance with CDC guidelines. Please note: All individuals entering our facilities are required to complete a self-health check, wear a mask and follow all posted guidelines.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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