Company: BEPC Inc. - Business Excellence Professional Consu
Posted on: May 9, 2022
BEPC has an open position for a Compliance Specialist in
Vacaville, CA!!Contract W2 Period: 1 Year contract with
possibilities for extensionsPay & Benefits: $67/hr. + Medical,
Dental, Vision and Life Insurance
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 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
- 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
- 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 system improvements.
- Be able to act as SME to regulatory agenciesEDUCATION:
- 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
- Proficient as a DMS Owner.
- Familiarity with CAPA, Change Control and Tracking
- Ability to make sound decisions about scheduling, allocation of
resources and managing priorities.
- Ability to lead cross functional teams to meet document
- 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
Didn't find what you're looking for? Search again!