The Fountain Group
The Fountain Group
is a national staffing firm and we are currently seeking a
QA Specialist - Risk Management
for a prominent client of ours. This position is in Worcester, MA 01605. Details for the position are as follows:
Job Title: QA Specialist – Risk Management (Senior QA Associate considered based on experience)
Location: Worcester, MA Schedule: Hybrid Pay Rate:
$43–$46/hour
Overview This role supports the Quality organization’s
Quality Risk Management (QRM)
activities within a GMP biologics manufacturing environment. The position is highly
documentation-driven
and compliance-focused, requiring close collaboration with cross‑functional technical teams to assess, document, monitor, and maintain risk management activities.
A candidate with a
science‑based background
who is comfortable working in regulated environments, managing complex documentation, and applying risk‑based decision‑making will be an excellent fit.
Key Responsibilities
Support and lead
Quality Risk Management (QRM)
activities across commercial biologic products and site operations.
Develop, update, and maintain
risk management documentation
related to:
Biologic drug substances
Site and operational risk
Cross‑contamination risk
Facilities, utilities, and equipment risk
Apply working knowledge of
ICH Q9 (Quality Risk Management) ; familiarity with
EU GMP Annex 1
is a strong plus.
Collaborate with
technical subject matter experts
to ensure risk documentation is accurate, current, and reviewed on schedule.
Perform
periodic reviews
of risk documents, manage document revisions, and identify obsolete records.
Track and monitor
open action items
resulting from risk assessments and ensure timely implementation.
Analyze data from multiple sources to identify
risk trends, recurring issues, and opportunities for improvement .
Prepare reports summarizing outputs of risk management monitoring activities.
Exercise sound judgement to
escalate risks appropriately , including documenting rationale when escalation is not required.
Provide QA compliance support as needed, including:
Investigations
Audits and inspection readiness
Continuous improvement initiatives
Top 3–5 Skills / Experience Required
Science‑related educational background
(Minimum bachelor's degree in biology, Chemistry, Biochemistry, or similar)
GMP manufacturing experience , preferably in biologics or sterile manufacturing
Hands‑on QA experience
supporting compliance, documentation, and inspections
Quality Risk Management experience , including risk assessments and mitigation tracking
Strong written and verbal communication skills
with the ability to work cross‑functionally
#J-18808-Ljbffr
is a national staffing firm and we are currently seeking a
QA Specialist - Risk Management
for a prominent client of ours. This position is in Worcester, MA 01605. Details for the position are as follows:
Job Title: QA Specialist – Risk Management (Senior QA Associate considered based on experience)
Location: Worcester, MA Schedule: Hybrid Pay Rate:
$43–$46/hour
Overview This role supports the Quality organization’s
Quality Risk Management (QRM)
activities within a GMP biologics manufacturing environment. The position is highly
documentation-driven
and compliance-focused, requiring close collaboration with cross‑functional technical teams to assess, document, monitor, and maintain risk management activities.
A candidate with a
science‑based background
who is comfortable working in regulated environments, managing complex documentation, and applying risk‑based decision‑making will be an excellent fit.
Key Responsibilities
Support and lead
Quality Risk Management (QRM)
activities across commercial biologic products and site operations.
Develop, update, and maintain
risk management documentation
related to:
Biologic drug substances
Site and operational risk
Cross‑contamination risk
Facilities, utilities, and equipment risk
Apply working knowledge of
ICH Q9 (Quality Risk Management) ; familiarity with
EU GMP Annex 1
is a strong plus.
Collaborate with
technical subject matter experts
to ensure risk documentation is accurate, current, and reviewed on schedule.
Perform
periodic reviews
of risk documents, manage document revisions, and identify obsolete records.
Track and monitor
open action items
resulting from risk assessments and ensure timely implementation.
Analyze data from multiple sources to identify
risk trends, recurring issues, and opportunities for improvement .
Prepare reports summarizing outputs of risk management monitoring activities.
Exercise sound judgement to
escalate risks appropriately , including documenting rationale when escalation is not required.
Provide QA compliance support as needed, including:
Investigations
Audits and inspection readiness
Continuous improvement initiatives
Top 3–5 Skills / Experience Required
Science‑related educational background
(Minimum bachelor's degree in biology, Chemistry, Biochemistry, or similar)
GMP manufacturing experience , preferably in biologics or sterile manufacturing
Hands‑on QA experience
supporting compliance, documentation, and inspections
Quality Risk Management experience , including risk assessments and mitigation tracking
Strong written and verbal communication skills
with the ability to work cross‑functionally
#J-18808-Ljbffr