Batch Record Reviewer
Company: Alpha Consulting
Location: Salt Lake City
Posted on: January 26, 2023
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Job Description:
*BATCH RECORD REVIEWER**SALT LAKE CITY, UT**Shift: Friday-Sunday
6:00 pm-6:30 am, 12-hour shift, 4 hrs can be added to make this a
40-hr. position.**Required Skills: ** High School Diploma or
equivalent required.* Associates Degree or higher (or equivalent)
achieved or in process preferred.* Minimum of one year experience
in a regulated environment such as pharmaceutical, medical device,
nutraceutical, or food processing industries.* Basic understanding
of Good Manufacturing Practice (cGMP) and the application to a
production environment.* 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 recommend methods and procedures for problem
resolution.* Physical Requirements:* Frequent sitting for extended
periods of time at workstation or mobile equipment.* Frequently
using fingers to perform activities such as picking, pinching, or
typing.* Frequent repetitive motions. (Frequent motions of the
wrists, hands and/or fingers)* Occasional:* Standing for extended
periods of time at workstation 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.*Project Description: **
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.* Responsible for ensuring all site and
regulatory requirements are satisfied for raw materials, labeling
materials, and packaging materials prior to release.* Responsible
for artwork review and approval, retain management and label
issuance as needed to support operations.* 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.This 6+ month position starts ASAP.ALPHA'S REQUIREMENT
#23-00141MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2
EMPLOYEEJob Types: Full-time, ContractBenefits:* 401(k)* Dental
insurance* Health insurance* Health savings account* Referral
program* Vision insuranceSchedule:* 12 hour shift* Night shift*
Weekend availabilityWork Location: One location
Keywords: Alpha Consulting, Salt Lake City , Batch Record Reviewer, Other , Salt Lake City, Utah
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