Quality Analyst I
Company: Aequor Technologies LLC
Location: Salt Lake City
Posted on: March 19, 2023
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Job Description:
Job Title - QA BBR Associate Production (more of an office
role)
Bill Rate: ***
Pay Rate: ***
Shift: M-F 8am - 5pm 40 hr. position
Please add the question and answers below to the resume or it will
be rejected:
1. # of years of experience in regulated environment (pharma,
medical device, food processing, ect)?
2. Experience with Data Mining ?
3. Previous Productions experience with batch record release?
4. Experience w/Documentation (collecting and managing information)
? (Describe)
5. Previous problem solving experience? (Describe)
6.) Experience with computers
POSITION SUMMARY
This position is responsible for monitoring production operations
through the use of multiple mechanisms including routine line
checks, line clearance activities, in-process inspection oversight,
providing general guidance and instruction to correct identified
deficiencies during documentation reviews and other oversight as
needed to ensure compliance with company procedures and domestic
and international regulatory requirements. This position is
responsible for ensuring all site and regulatory requirements are
satisfied for raw materials, labeling materials, and packaging
materials prior to release. This position is responsible for
artwork review and approval, retain management and label issuance
as needed to support operations.
ESSENTIAL AREAS OF RESPONSIBILITY
All areas of responsibility listed below are essential to the
satisfactory performance of this position by any incumbents with
reasonable accommodation if necessary. Any non-essential functions
are assumed to be included in other related duties or
assignments.
" Responsible for collecting, assembling, and managing information
and making appropriate decisions on approval or rejection for all
components, drug product containers, in-process materials,
packaging materials, labeling, and drug products manufactured.
" Responsible for conducting Foreign Matter Investigations as
needed for materials throughout the lifecycle of the receipt,
sampling, testing, dispensing and other in-process stages of
material use.
" Responsible for receipt, log in and management of incoming
retains and in-house retains. This includes management of annual
inventory, annual product reviews and destruction of materials
which have exceeded expiry.
" Responsible for serving as a QA first responder for various
issues that occur on the manufacturing/ packaging floor and/or
during batch record documentation/review and providing directions
for situations of low complexity; moderate to high complexity
situations must be deferred to more senior QA personnel.
" Responsible for labeling issuance, review and/or returns;
document processing including data entry, data verification and/or
processing/controls of documentation.
" Responsible for participating in investigations and providing
recommendations for corrective actions and prevention of
recurrence.
" Responsible for writing, revising or reviewing Standard Operating
Procedures (SOP s), forms and/or Work Instructions with changes of
low complexity and responsible for ensuring accuracy and GMP
compliance in documents that are being reviewed such as artwork,
raw material files, AQL inspection forms, and labeling.
" Responsible for performing additional related duties as
assigned.
POSITION REQUIREMENTS
Any equivalent combination of education, training and/or experience
that fulfills the requirements of the position will be
considered.
Education/Certification/Experience:
" Requires High School Diploma or equivalent.
" Requires a minimum of one year experience in a regulated
environment such as pharmaceutical, medical device, nutraceutical,
or food processing industries.
" Requires basic understanding of Good Manufacturing Practice
(cGMP) and the application to a production environment.
" Associates Degree or higher (or equivalent) achieved or in
process preferred.
Skills/Knowledge/Abilities:
" Computer proficiency with comprehensive working knowledge of MS
Office products, Learning Management Systems (LMS), ERP systems
such as SAP or Oracle and manufacturing/quality systems such as
LIMS, Trackwise and Qdocs.
" Self-directed with ability to organize and prioritize work.
" Ability to communicate effectively with excellent written and
oral communication skills.
" Ability to interact positively and collaborate with co-workers,
management and external partners.
Problem Solving:
" Proactively works on problems where evaluation of contributing
factors requires the analysis of situations or data and an in-depth
knowledge and evaluation of various known and unknown factors.
" Seeks out all resources when selecting methods and techniques for
obtaining results.
" Acts independently and may proactively to recommend methods and
procedures for problem resolution.
TRAVEL REQUIREMENTS
" N/A
PHYSICAL REQUIREMENTS:
Frequent:
" Sitting for extended periods of time at work station or mobile
equipment
" Using fingers to perform activities such as picking, pinching or
typing.
" Repetitive Motions (frequent motions of the wrists, hands and/or
fingers)
Occasional:
" Standing for extended periods of time at work station or
equipment
" Walking to move short distances quickly and frequently
" Stooping, kneeling and/or crouching
" Twisting/Reaching turning at waist and extending hands and/or
arms in any direction
" Grasping applying pressure to an object with the fingers and
palm
Keywords: Aequor Technologies LLC, Salt Lake City , Quality Analyst I, Professions , Salt Lake City, Utah
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