Compliance Specialist
Company: SSI
Location: Framingham
Posted on: February 20, 2021
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Job Description:
Core ResponsibilitiesThe Senior Compliance Specialist is
responsible for providing quality support and direction to
Manufacturing, Quality Control, and support functions to ensure
continued compliance to CGMPs as well as being responsible for
providing technical support serving as a Subject Matter Expert
(SME) to the QA team.--- Actively supports the QA Operations team
by providing technical support--- Completes Phenix/Trackwise
Laboratory Investigations/Deviations/CAPA/Change Controls--- Ensure
all safety requirements are being met--- Performs batch record and
logbook review--- Performs review of column packing and
qualification records--- Review and approve CRs related to EBRs---
Function as SME on challenges related to production requiring
quality input--- Provide on the floor (OTF) support to the
operations department, including OTF support for critical
operations steps--- Issue action notices and conduct affiliated
provisional release--- Conduct log book audits against compliance
requirements--- Review CV related documentation against
specification--- Perform media / buffer and intermediate release---
Perform release of Cell Banks for forward processing (as
applicable)--- Support cross-functional internal audit activities
and conduct walkthrough inspections--- Execute containment
activities--- Provide expertise during procedure/SOP revision
process and function as DCR approver for department related SOPs
and PRs--- Maintain a high level of personal compliance to the
required standards--- Partner with manufacturing and support
operations to ensure a culture of continuous compliance
Basic Qualifications:--- Master's Degree & 2 years of experience or
Bachelor's Degree and 4 years of experience in a Quality and /or
other cGMP related field.--- Knowledge in external agency
regulations (FDA, EMA, etc.)--- Strong computer, verbal and written
communication skills.--- Experience in quality systems.---
Experience with Trackwise or equivalent system.--- Proficient in
Microsoft OfficePreferred Qualifications:--- Operations experience
in one of the following areas: Quality Assurance, Quality Control,
Manufacturing Technical Support, Facilities Engineering, or
Automation.--- Experience with root cause analysis tools.---
Demonstrated experience with change control, CAPA and deviation
quality systems.--- Experience in a Quality Assurance role.---
Strong technical writing skills.--- Effective time management,
attention to detail, organizational skills, teamwork and
collaboration.--- Significant capability in problem solving
methodology.--- Experience training and technically developing
employees.--- Experience participating in external agency
inspections.--- Knowledge of regulatory enforcement trends.---
Ability to work independentlySpecial Working Conditions:--- Ability
to gown and gain entry to manufacturing and Quality Control
areas.--- Ability to work a 12-hour rotating shift and every other
weekend, including holidays.--- Ability to lift 10 lbs. - provided
by Dice
Keywords: SSI, Framingham , Compliance Specialist, Other , Framingham, Massachusetts
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