Company: BEPC Inc. - Business Excellence Professional Consu
Posted on: May 9, 2022
BEPC has an open position for a Compliance Specialist in
Contract W2 Period: 1 Year contract with possibilities for
Pay & Benefits: $67/hr. + Medical, Dental, Vision and Life
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
Vacaville Manufacturing Facility by overseeing Quality System
records and providing consultative subject matter expertise as a
compliance expert within Facilities and Engineering.
Serve as an example and advocate of engrained quality
Solve a wide range of difficult issues that impact multiple
functions following cGMP regulations and Genentech standards by
applying advanced theory, technical principles and expert
Troubleshoot and facilitate the resolution of Quality issues by
fostering effective interdepartmental and cross-functional
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
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
Provide input into the design and presentation of departmental
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
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
Escalate process issues as necessary to ensure resolution of
Comply with cGMP, SOP and manufacturing documentation.
Train Facilities & Engineering team members and contribute to the
improvement of compliance related training material and
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
Contribute to a LEAN work environment by acting as a change agent
and utilizing OE Tools. Identify, design and implement process and
Be able to act as SME to regulatory agencies
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,
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
Strong organizational and project coordination skills.
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
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.
Keywords: BEPC Inc. - Business Excellence Professional Consu, Vacaville , Compliance Specialist, Other , Vacaville, California
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