Job #
24271
Title: Operations
Associate
Location: Waltham,
MA
Duration: Direct Hire
POSITION
SUMMARY:
The primary
responsibility of this associate will be to provide support for GMP
manufacturing operations. This role will include responsibilities
in materials management and facilities operations.
The position
will be responsible for materials shipping and receiving, inventory
control, labeling and transport. This role will also support
product and sample shipments. Additionally, this individual will be
responsible for coordination of external contractors involved with
facility repairs, certification and calibration. The work
environment is dynamic and the successful candidate will require
cross-disciplinary teamwork, a “can-do” attitude, and the ability to
be an individual contributor supporting the Quality and
Manufacturing departments whenever called upon.
MAJOR DUTIES AND
RESPONSIBILITIES:
-
Responsible
for maintenance of GMP raw materials system (including
receiving, inspection, labeling, inventory control, issuance and
transfers).
-
Responsible
for general shipping and receiving.
-
Assist with
materials planning and procurement and vendor communications.
-
Assist with
shipment of investigational product, test samples and research
samples.
-
Coordinate
contractors involved in facility and equipment repairs,
cleaning, certifications, calibrations and validations.
-
Maintain
schedules for routine contractor activities and coordinate with
manufacturing and quality staff.
-
Assist in
monitoring of facilities, utilities and equipment to ensure
continuous facility operations.
-
Complete &
maintain documentation associated with the stated activities.
-
Responsible
for the periodic review of current effective procedures,
revisions to procedures, and drafting new procedures as
necessary.
QUALIFICATIONS:
-
Three to
five years experience in GMP materials management.
-
GMP
facilities / operations experience a plus.
-
Familiarity
with relevant ISO, FDA and cGMP regulations and guidelines.
-
Must be able
to lift up to 50 lbs without assistance.
-
Strong
initiative and ability to work with minimal supervision
-
Ability to
work on assignments of moderate complexity in collaboration with
various departments.
-
Demonstrated
ability to work accurately, follow
instructions/schedules/timelines and handle multiple priorities
and adapt to changes in priorities.
-
Attention to
detail and precise record keeping
-
Professional, well-organized, and eager to learn and be
challenged
-
Fluency in
Windows and Microsoft Office (Word and Excel at the minimum)
-
Bachelors
degree preferred
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