5555 Compliance Specialist
Summary:
Responsible for providing Front Line Engineering compliance oversight in a cGMP (current Good Manufacturing Practices) environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for process management.
Maintain records to comply with regulatory requirements utilizing (cGMP) and Standard Operating Procedures (SOP).
Support the Manufacturing Facility by overseeing Quality System records and providing consultative subject matter expertise as a compliance expert within Facilities and Engineering.
Job Responsibilities:
Quality Systems:
Serve as an example and advocate of engrained quality
Solve a wide range of difficult issues that impact multiple functions following cGMP regulations and the Company standards by applying advanced theory, technical principles and expert judgment.
Troubleshoot and facilitate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnership.
Review controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product and approve changes as appropriate
Lead or participate in discrepancy investigations and Root Cause Analysis (RCA) as well as interact with interdepartmental contacts ensuring discrepancy identification, definition, assessment, and resolution
Act as an Unplanned Event Owner Lead:
Issue, assess as needed and follow up on assessments
Performing recurring unplanned event assessment
Summarizing the unplanned event
Initiate/Own remediation actions as needed.
Perform track and trend on discrepancies within Facilities and Engineering
Provide input into the design and presentation of departmental performance metrics
Generate, track and trend departmental performance metrics
Represent F&E as a planned event owner and responsible for CAPA actions, as required
Perform any other tasks as requested by management to support Facilities and Engineering
Provide a regular presence on the floor to ensure Facilities and Engineering personnel are operating within the confines of the local procedures and regulatory requirements
Technical:
Follow established safety and environmental guidelines and procedures for all work performed.
Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions
Fosters safe work practices and champions safety improvements
Act as a Facilities and Engineering technical subject matter expert (SME) supporting cause analysis and remediation planning
Exhibit detail-oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)
Escalate process issues as necessary to ensure resolution of issue
Comply with cGMP, SOP and manufacturing documentation.
Train Facilities & Engineering team members and contribute to the improvement of compliance related training material and practices
Troubleshoot process equipment and systems or lead troubleshooting efforts to resolve complex process issues
Communicate effectively and professionally work in a team environment. Serve as department representative on cross-functional teams.
Contribute to a LEAN work environment by acting as a change agent and utilizing OE Tools. Identify, design and implement process and system improvements.
Be able to act as SME to regulatory agencies
Education:
BS/BA degree (preferably in Life Science) and at least five years experience in the pharmaceutical, biopharmaceutical industry, working in a cGMP manufacturing environment, or an equivalent combination of education and experience.
Experience (may vary depending on site size/scope):
Sound knowledge of cGMP and equivalent regulations (such as EMA, FDA).
Proficient as a DMS Owner.
Familiarity with CAPA, Change Control and Tracking Actions.
Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
Ability to lead cross functional teams to meet document management requirements.
Strong organizational and project coordination skills.
Knowledge/Skills/Competencies:
Strong oral and written communication skills.
Full understanding of computer-based systems
Ability to make sound decisions with minimal supervision.
Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.
Ability to read and understand engineering documents (such as P&ID, AFR, Visio)
Experience in creation and revision of Standard Operating Procedures and Manufacturing Formula is desirable.
Work Environment/Physical Demands/Safety Considerations:
Standard office environment
No make-up or jewelry can be worn when working in the clean room environment.
Work around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems.
Flexibility in problem solving and work hours to meet business objectives
Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers per procedures and posted instructions .
Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.
Usage of hearing protection and dust masks may be required.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.