Quality Assurance Manager
Company: SOFIE
Location: Van Nuys
Posted on: April 25, 2024
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Job Description:
Overview
SOFIE is committed to all aspects of Quality and Compliance in the
manufacture of Radiopharmaceutical products. This role provides
Quality leadership to defined SOFIE facilities (and the network).
SOFIE aseptically manufactures therapeutic and diagnostic
radiopharmaceuticals across the US. The successful candidate will
play an active and integral part of the Quality team supporting
compliance and improvement for an assigned SOFIE facility (or
facilities). The applicant will be responsible for the Quality
Management System (QMS) at the given SOFIE facility (or facilities)
and manage the site Quality Assurance Specialist(s). The candidate
must be strong at technical and quality writing, root cause
analysis, identifying trends, and establishing and implementing
robust corrective and preventive actions. The candidate must also
be able to learn technical, scientific, and quality processes to
aid in the oversight of SOFIE and Partner drug products.
Essential Duties and Responsibilities
--- Ensure compliance to all applicable standard operation
procedures (SOPs) and regulations, including 21 CFR Part 211 and
212 requirements, by implementing an effective and efficient
quality management system and maintaining a state of cGMP control
for sites within a given region.
--- Provide Quality Leadership to develop, maintain, and
continually improve the Quality Management System (QMS).
--- Oversee all quality-related activities of routine
radiopharmaceutical manufacture and directly supervise site-level
Quality Assurance Specialists within a given facility or
facilities.
--- Release clinical and commercial finished product batches, final
drug product labels, reagents, manufacturing batch records,
associated EM data, QC analytical testing results, and
Certification of Analysis for conformance to SOPs, specifications,
regulations, and other applicable acceptance criteria to ensure
compliance and product quality as required.
--- Review, edit, and approve Change Control, Deviation, OOS
investigation, and CAPA for sites. Closely track and follow up on
these activities for timely closure. Ensure that scientifically
sound investigations are conducted and root causes are identified.
Initiate and implement CAPA plans. Evaluate the effectiveness of
the CAPA plans through reporting and trending.
--- Author, review, and approve cGMP documents, including various
procedures, protocols, specifications, reports, records, and
changes to these documents.
--- Monitor and oversee the ongoing training program to qualify the
site QASs to follow SOPs to perform their job functions at all
times. Ensure the training covers any newly released procedures,
revised procedures, and cGMP updates. Track individuals' training
requirements and ensure all trainings are on time and
documented.
--- Ensure aseptic operations are in compliance with internal
procedures (gowning, cleaning/sanitation, sterility, environmental
monitoring, etc.), customer requirements, and FDA regulations for
sites within a given site. Assure completeness, accuracy,
traceability, and compliance of the site's utility and facility
monitoring methods and records.
--- Monitor the metrology program for given site(s). Ensure that
all equipment is appropriately maintained, calibrated/recalibrated,
or validated/revalidated in a timely manner. Ensure a comprehensive
tracking system is implemented and followed.
--- Ensure that raw materials, components, containers, closures,
packaging, and labeling are inspected, qualified, and meet
acceptance criteria before use for sites within a given region.
Ensure all materials are properly organized, controlled, and
secured.
--- Provide QA oversight of manufacturing, QC, and other cGMP
activities for sites within a given region. Identify non-
compliance problems and propose solutions as appropriate.
Effectively interact with other functional personnel at the
site-level and resolve quality related issues.
--- Regularly conduct internal self-audit for quality management
system effectiveness for sites within a given region. Document the
findings in a self-audit report. Initiate action plans to prevent
cGMP non-compliance and product quality problems proactively.
Ensure continuous and sustained improvements.
--- Liaise with corporate QA audits, customer audits, and
regulatory agency audits. Perform readiness assessment
--- Other responsibilities as required.
--- The description provided above is not intended to be an
exhaustive list of all job duties, responsibilities, and
requirements. Duties, responsibilities, and requirements may change
over time and according to business need.
Qualifications
--- Bachelor's Degree required (science, technical, or quality
degree preferred)
--- 4+ years of work experience in Quality Assurance in a cGMP
pharmaceutical and/or biological manufacturing regulated
environment.
--- 2+ years' supervisory experience within a Quality Assurance or
Quality Control function.
--- Experience leading internal audits preferred.
--- Knowledge of USP, FDA, and cGMP regulations preferred.
--- Excellent analytical, prioritization, multi-tasking,
communication, strong leadership skills, and the ability to work
independently with limited supervision required.
--- Ability to effectively communicate (written and verbal) with
site personnel, corporate QA, customers, and regulatory agencies
required.
--- Ability to prepare and present written and verbal reports to
upper management required.
--- Experience and/or full knowledge of manufacturing operations,
preparation of sterile injectables, aseptic processing, and
distribution of aseptic products preferred.
--- Knowledge of how and ability to write, review, and revise
exception reports and SOPs required.
--- Ability to read, analyze, and interpret governmental
regulations, general business periodicals, professional journals,
or technical procedures required.
--- Ability to read and interpret documents such as safety rules,
operating and maintenance instructions, and procedure manuals
required.
--- Ability to write reports, business correspondences, and
procedure manuals required.
--- Ability to effectively present information, deliver training,
and respond to questions from groups of colleagues, managers,
partners, and customers required.
--- Ability to define problems, collect data, establish facts and
draw valid conclusions required.
--- Ability to solve problems and handle issues required.
--- Proficient in MS Office applications required.
--- Travel: up to 40% domestically.
Keywords: SOFIE, Gardena , Quality Assurance Manager, Executive , Van Nuys, California
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