Quality Assurance Specialist New York
Company: SOFIE Co.
Posted on: September 21, 2023
The Quality Assurance Specialist will be responsible for the
oversight of the Quality Assurance program and the Quality
Management System at the site level.
Essential Duties and Responsibilities
--- Maintain oversight of the QA program and Quality Management
System (QMS) at a single SOFIE manufacturing facility producing
products under both 21 CFR Part 212 and 211 (as needed)
--- Apply quality assurance processes and procedures at the site
level to ensure product quality and regulatory compliance.
--- Write, review, approve, and implement procedures,
specifications, processes, and methods as required.
--- Oversee the examination and evaluation of each lot of incoming
material before use to ensure that the material meets its
--- Ensure that components, containers, closures, in-process
materials, packaging materials, labeling, and finished dosage forms
are examined and approved or rejected to ensure that all these meet
their current specifications.
--- Ensure that personnel is properly trained and qualified. Ensure
that the training is documented.
--- Conduct periodic audits of the site to monitor compliance with
established procedures and practices. May infrequently audit
--- Liaise with internal and external inspectors and
representatives, particularly on QA-related topics.
--- Oversee the metrology program at the site (i.e., equipment,
personnel qualifications, validations, etc.).
--- Ensure manufacturing and analytical equipment is appropriately
maintained and calibrated. Ensure applicable facility
certifications are maintained. Identify management problems in
personnel, equipment, and the facility that requires
--- Review documents associated with the site's QA program for
completeness, errors, and omissions. A review executed CGMP records
and product batch records to ensure compliance and product
--- Review trends (e.g., environmental monitoring, deviations,
facility issues, etc.) to initiate corrective and preventive
actions and/or for continuous process improvement.
--- Conduct a continuous review of aseptic operations to ensure
compliance to internal procedures (e.g. gowning, cleaning,
sanitation, sterility, environmental monitoring, etc.) and USP/FDA
--- Ensure any deviations from normal procedures are documented and
--- Ensure an investigation is performed and documented when
required, and corrective and preventative actions are taken (i.e.,
follow and maintain corporate CAPA, deviation, and OOS
--- Ensure compliance with all applicable standard operating
procedures and regulations, including 21 CFR Part 212 (and 211 as
--- Ensure product complaints are handled in a manner consistent
with Company SOPs and FDA regulations.
--- Responsible for opening change controls and initiating,
maintaining, and reviewing SOFIE network and site-specific
procedures relative to their job functions.
--- Oversee the site-level change control process. Ensure that
changes in the laboratory are accepted or rejected as appropriate,
and ensure the changes are appropriately documented.
--- Attend quality and operational meetings. Interface with
Corporate QA and Operations on quality-related issues. Provide
status updates as required by management.
--- Other responsibilities as required.
--- Bachelor's Degree (B.Sc. preferred.)
--- Experience and/or full knowledge of manufacturing operations,
preparation of sterile injectables, aseptic processing, and
distribution of aseptic products preferred.
--- Knowledge of USP, FDA, and cGMP regulations preferred.
--- Knowledge of how and ability to write, review, and revise SOPs
--- 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
--- Ability to write reports, business correspondence, and
procedure manuals required.
--- Ability to effectively present information, deliver training
and respond to questions from groups of managers, clients,
customers, and the general public 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.
--- Strong interpersonal communication skills for interacting with
site personnel, inspectors, and internal and external vendors
--- Document Originator & Reviewer Approval Signatures
Keywords: SOFIE Co., Albany , Quality Assurance Specialist New York, Other , Albany, New York
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