ROLE SUMMARY
The Quality Inspector will be able to audit GMP documents for
aseptic pharmaceutical processes for conformance to established
specifications, procedures, cGMPs, and FDA regulations and
identify non-conformances. The position requires excellent written
and oral communication skills and the ability to work effectively
across multiple departments to achieve initiatives. Quality
Inspectors must be able to work well with personnel at all levels
throughout the organization including peers, operations personnel,
supervisors and managers. This role requires the ability to perform
job related tasks at a high level independent of direct supervision.
ROLE RESPONSIBILITIES
The essential functions of the position may include, but are not
limited to:

• Communicate non-conformances found during aseptic

processing operations to the QA Supervisor/Manager on
shift

• Follow established procedures and identify gaps as written
• Attend/participate in monthly In Process Batch Record

Review

• Floor QA point of contact to MQA and Production

Management

• In-process review of production batch records for accuracy

of documented entries and conformance to established
procedures

• Perform inspection readiness walk-throughs, line clearance,

in-process checks and verifications in support of
manufacturing activities

• Must be able to complete aseptic gowning qualification and

work daily in a Grade A/B classified area

• Understand and demonstrate aseptic techniques and

behavior required in aseptic processing areas

• Observe for aseptic techniques during processing and

ensure process interventions are performed per procedures

• Perform quarantine and rejection of basic units,

components, material, etc. Perform PRISM transactions, as
applicable

• Must be willing to work overtime to support business

initiatives

• Weekend hours (Saturday and/or Sunday) may be required

QUALIFICATIONS

• High School degree required; Bachelor’s degree in a

scientific discipline is preferred.

• Minimum of 1-3 years of related experience and/or

successful completion of a job-specific training program or
equivalent combination of education and experience is
recommended.

• The ideal candidate will possess a combination of relevant

education and work experience, and/or successful
completion of a job-specific training program.

• Non-Standard Work Schedule, Travel or Environment

Requirements.

• Must be willing and able to work beyond the hours typically

defined as a “regular” workday, which may or may not
include weekends and holidays.
PHYSICAL/MENTAL REQUIREMENTS:
While performing the duties of this job, the employee is occasionally
exposed to work near moving mechanical parts. The noise level in
the work environment is usually moderate. While performing the
duties of this job, the employee is occasionally required to stand;
use hands to finger, handle or feel; reach with hands and arms;
climb or balance; walk; sit and talk or hear. The employee must
occasionally lift and/or move up to 25 pounds. While performing the
duties of this job, the employee must don a full body garb suit, hood,
mask, goggles, and gloves. The employee will also be required to
remain in the full body garb suit, hood, mask, goggles, and gloves
for several hours at time.
Must have schedule flexibility, depending on the production
schedule employees may be required to periodically work overtime,
off-shifts (mornings, afternoons, nights or a combination of both),
weekends and/or holidays. Position requires regular onsite
attendance – this position cannot be performed on a remote or
telecommute basis on a temporary, short- or long-term basis.
Must have the ability to simultaneously multi-task across multiple
capabilities and functions and handle multiple competing priorities
and requirements, including performing site and functional
responsibilities, responding to frequent e-mail and phone
communications and attending multiple meetings and conference
calls. Note that these activities may not be time bound to core hours
or presence at the site.
Must have the ability to work effectively under pressure and conform
to strict production, time and performance deadlines.
This is a full-time position in the production floor / Aseptic area.

• Must be willing and able to work beyond the hours typically

defined as a "regular" workday, which may or may not
include weekends and holidays, and hours outside defined
shift hours.

• Must be able to gown aseptically.