Senior Quality Specialist - 3rd Shift
Company: Alcami Corporation
Location: Durham
Posted on: May 25, 2023
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Job Description:
Position Summary
The Senior Quality Specialist is accountable for driving results in
a fast-paced environment by effectively performing activities of
substantial variety and complexity to ensure quality and compliance
with applicable regulatory requirements and is proficient in all
document and protocol approvals applicable to the respective
processes executed at the respective lab or manufacturing
facility.These activities include reviewing documents and data,
conducting audits and inspections, consulting on quality and
compliance issues, maintaining quality databases and performing
trend analysis where needed, and performing quality and compliance
training as needed.The position serves as quality host for client
and regulatory agency audits and inspections.The position develops
SOPs or other quality documents as needed.The position provides
guidance and mentoring for other Quality employees. Serves as a
back-up to site Quality Management for technical Quality decision
making.The position requires superior leadership behaviors of the
Alcami core competencies and non-negotiables, as well as expertise
in functional competencies included in this position profile.This
position will work 2nd shift, Monday through Friday.
Essential Functions
Education and Experience
Alcami Non-Negotiables
Alcami Core Leadership Competencies
Functional Competencies
Decision Making and Supervision Required
Travel Requirements
Physical Demands and Work Environment
The physical demands and work environment characteristics described
here are representative of those that must be met by an employee to
successfully perform the essential functions of this job.Reasonable
accommodations may be made to enable individuals with disabilities
to perform the essential functions. While performing the duties of
this job, the employee may be required to use hands to finger,
handle, or feel and to reach with hands and arms. The employee is
required to talk and hear.The employee is frequently required to
stand, walk and sit.The employee may be occasionally required to
climb or balance.The employee may be required to regularly lift
and/or move up to 10 pounds, frequently lift and/or move up to 25
pounds and occasionally lift and/or move up to 50 pounds.Specific
vision abilities required by this job include close vision,
distance vision, and peripheral vision. While performing the duties
of this job, the employee may be occasionally exposed to moving
mechanical parts, high precarious places and vibration.The noise
level in the work environment is usually quiet.The employee may be
required to gain access to lab, or manufacturing areas for
inspections or work discussions.The noise level in these additional
work areas may be louder. The employee is required to wear the
appropriate personal protective equipment to perform the job
duties.Such personal protective equipment may include but is not
limited to:safety eyewear, various types of respirators/breathing
apparatus, lab coats, gloves, etc.
Other Duties
Please note this job description is not designed to cover or
contain a comprehensive listing of activities, duties or
responsibilities that are required of the employee for this job.
Duties, responsibilities and activities may change at any time with
or without notice.
Keywords: Alcami Corporation, Durham , Senior Quality Specialist - 3rd Shift, Other , Durham, North Carolina
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