Investigations Coordinator
3 days ago
Summary: Support the
I
nvestigation
T
eam by compiling data and
required
documentation for investigations
.
Maintain the Investigation Huddle board and associated Investigations tracking files
.
Assist the
I
nvestigation
T
eam by monitoring and reporting metrics
to proactively
identify
risks for action assignment
.
Generate data and track key performance metrics in support of creating quarterly trend reports
.
Participate
and contribute to
departmental
meetings and huddles
.
Revise standard operating procedures (SOPs) for investigations when
required
.
Essential Functions: Support
the maintenance of the Investigation Huddle board and associated Investigations tracking files.
Revise Investigation
procedure
s through
eDMS
when
required
.
Support the Investigations Team by compiling data and supporting documentation
for
assigned
investigations
(
i.e.
pull SFLMS training reports, SOPs that were effective at the time of the event, etc.).
Support
minor investigations.
Support the investigation team to meet all necessary administrative tasks
in a timely manner
.
Support the Investigation Team Lead as
required
.
Support investigation related
projects.
Maintain a safe working environment and
reports
potential hazards.
Perform alternating or rotating shift work (as
required
)
.
REQUIRED QUALIFICATIONS
Education: H
igh school diploma/
General Educational Development (GED) Certificate is
required Working towards a
Bachelor of Science (B.Sc.) in chemistry, biology, life sciences
,
or a related field
Experience: Requires no
previous
related
experience.
Equivalency
: Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills
,
and Abilities
: Strong interpersonal skills.
Knowledge of G
ood Manufacturing Practices, Standard Operating
Procedures,
and Corrective Action Preventative Action (CAPA)
is an added value
. Good organizational skills with
a
proven ability to prioritize when timeline conflicts exist. Detail oriented.
Ability to discretely deal with Confidential information
.
Demonstrated computer
proficiency
with Microsoft Office programs
.
Proficiency
with the English Language.
Standards and Expectations: Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members,
modeling
positive team principles and partnering to meet project and departmental
objectives
. Carry out all duties within strict compliance
to
Patheon quality
SOPs
and Good Manufacturing
Practices
(GMP). Maintain workspace in a clean and orderly fashion.
Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.).
Be client and patient conscious at all times.
Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in
problem-solving
.
Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively
identify
areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner.
Consistently
strives
to improve skills and knowledge in related
fields
.
Physical Requirements: Light physical effort and fatigue. Walks
,
sits
,
or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for
a
limited duration. Typically
located
in a comfortable indoor area
.
There may be regular exposure to mild physical discomfort from factors such as dust, fumes or
odors
, temperature extremes, loud noise, strong drafts, or bright lights.
Use of Personal Protective equipment may be
required
and may include any of the following: s
afety glasses, safety shoes, lab coat, gloves,
hair net, beard cover,
safety apron,
and
respirator
occasionally
.
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