BD (Becton, Dickinson and Company) Sr. Quality Systems Specialist Compliance in Miami, Florida

Job Description SummaryThe Sr. Quality Systems Specialist Compliance is accountable and responsible for the Documentation management system using SAP, facilitating revisions and creation of documents. Management of BD Miami paper based documentation records: creation, filing and retention. Owner of the Learning Management System (LMS), oversee Calibration system compliance.

Job Description

  • Perform administration duties of the Document Control and Engineering Change Order (ECO) activities in accordance with GMP and quality standards.

  • Maintains and coordinates documentation as required by the manufacturing facility such as Batch Records, Log Books, Calibration Records, and other documentation activities as required.

  • Maintains, controls, verifies, and ensures ECO's are processed using Quality Documentation Management Systems or another electronic system is accurate and in a timely manner.

  • Responsible for supporting Master Data Activities for New Product Activation and Evaluating Master Data impact.

  • Develop/Revise Quality Inspection Plans in SAP including: incoming, in-process, and final inspection.

  • Manage the administration of the Document Retention program.

  • Design, develop and writing Standard Operating Procedures (SOPs) as needed to support custom and P2P

  • Support material release, and disposition “End to End” (E2E), and collaborate in all investigations related to materials following Quality Systems.

  • Manage the labelling system process which encompasses Master Label System Maintenance, Label Changes and Label Issuance and Control.

  • Provides quality support to Advanced Bioprocessing Miami projects and future Advanced Bioprocessing projects.

  • Performs other duties, projects, as assigned.

  • Ensure Compliance As System Administrator of the Training System “Compliance to Capability” System (C2C):

  • Maintain training records for Advanced Bioprocessing Miami associates in accordance with Corporate and Site Quality Policies.

  • Collect and record training in C2C for instructor-led, On-Job-Training, and other 3rd party training for plant associates.

  • Maintain E-Signature files for C2C.

  • Develop training requirements for associates with department supervisors.

  • Support updates to associate training requirements for new procedures and add to the appropriate C2C curricula.

  • Create training items following the C2C governance rules.

  • Create scheduled course offerings in C2C upon request.

  • Provide C2C technical support to Advanced Bioprocessing Miami associates.

  • Provide training compliance reports to functional site leadership on a monthly basis.

  • Manage data collection of plant level data for materials within a BD site for all materials type.

  • Manage and ensure compliance of the assigned Quality systems: Learning Management Systems, Documentation Management System.

Qualifications:

  • Strong knowledge of quality system regulations/requirements (i.e. ISO 9001:2000, 21 CFR Part 211/ 210, Part 601/610, Part 1271, Part 820 and cGMP/GLP and USP, EPA regulations).

  • Good understanding of Good Manufacturing Process including manufacturing, packaging process, aseptic and sterile fill process and systems.

  • Strong in application of technical principles, practices and procedures.

  • Experience on Quality Systems computer applications: SAP, TrackWise, and Electronic Documentation Systems.

  • Effective communication skills at all levels both written and verbal.

  • Ability to work with internal functional groups to ensure document compliance.

  • Effective skills in analytical thinking and problem solving.

  • Ability to perform multiple tasks and ability to effectively manage conflict.

  • Ability to work in teams to obtain results, self motivated/directed, ability to organize activities, minimal supervision required.

  • Basic to intermediate proficiency in Microsoft Office and statistical programs (i.e. MiniTab, SAS)

Education

  • Minimum of BS degree in Life Sciences (Microbiology, Biochemistry, Molecular Biology with 2 years of Microbiology course work)

Experience

  • Minimum of 5 years of experience in a Pharmaceutical, Biotech. Familiar with aseptic filling environment.

  • Experience on Quality Systems computer applications: SAP, TrackWise, and Electronic Documentation Systems.

  • SAP experience

DESIRED EXPERIENCE

  • Minimum of 5 years manufacturing experience.

  • Knowledge of Quality Systems, specifically ISO 9001:2008 and 21 CFR Part 820, 210 or 211

  • Worked in a fast pace manufacturing facility with shifting priorities.

  • Experience in contract manufacturing.

WORKING CONDITIONS:

  • Ability to lift up to 25 pounds repetitively, and up to 65 pounds non-repetitively.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

#LI-OPS

Primary Work LocationUSA FL - Miami

Additional Locations

Work Shift1st Shift 830am-5pm (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status