Quality Assurance Document Control
Company: Abacus
Location: Philadelphia
Posted on: April 26, 2024
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Job Description:
Description/Comment: QADC
BASIC FUNCTION:
The position requires the individual to prepare customer files,
review and approve batch records, and release batch records and
finished product. The individual acts as the primary liaison to our
customer's quality assurance groups for batch record review and
release. The position requires communication between the
operations/production, project management, shipping and quality
assurance groups to ascertain pertinent information relating to the
contract packaging orders.
SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES:
--- Review and approve all batch records prior to production to
ensure that they conform to requirements of cGMP and Clinical Trial
Protocol.
o Includes review of material status, protocol conformance,
clinical design layout, ensuring blinding techniques are
followed.
--- Monitor schedule for production priorities.
--- Attend scheduling meetings when needed.
--- Review of completed batch record for conformance with protocol
and appropriate cGMP and ensure that any changes are performed
according to procedures.
--- Confirm proper randomization schedule utilization for correct
patient treatment group assignment.
--- Primary liaison with client for batch release.
--- Communicate with other functions to resolve inconsistencies
with proper recording and completion of the batch record and
associated documentation. Communications may include educating
other functions to ensure compliance to regulations, procedures and
client requirements.
--- Ensure timely release of batch for protocol initiation
date.
--- Release batch within Scheduling database.
--- Release batch within JDE inventory management system.
--- Record and track errors and not-right-first-time to maintain
departmental metrics.
--- Archive batch documents onto shared drive and within archive
room.
--- Ensure that responsibilities are completed efficiently while
maintaining Quality.
--- Promotes a positive working environment.
--- Coach new QADC staff through day to day activities when
needed.
--- Communicates SQDC counter measures and safety issues to Quality
Management.
--- Ensures QADC metrics are met or takes action to correct.
--- Complies with EH&S and 5S requirements for QADC.
--- Other tasks or projects as assigned.
POSITION REQUIREMENTS:
Supervises: N/A
Education or Equivalent: BA/BS or High School Diploma with relevant
industry experience.
Knowledge/Skills Requirements: (List unique knowledge skills, or
problem-solving requirements)
o Attention to detail
o Good organizational/time management skills
o Exercises sound judgment and analytical in thought
o Challenges status quo and initiates improvements
o Ability to multi-task
o Communication skills
o Good math skills
o Basic computer skills Start Time: 12:00 AM Hours: 8:00am to
5:00pm Location: 112 10381 Decatur Rd 05-0591182 Philadelphia PA
19114 United States Education: dditional Job Details: P.15 ONSITE -
Contract for 12 months SHIFT - M-F 11 AM TO 730 PM TRAINING WILL BE
AM HOURS FOR 3 MONTHS - 10 AM TO 630 PM. VET ACCORDINLY THIS IS NOT
NEGOTIABLE This position will be doing Batch record review and
approval, support all QA Document Control Functions including
filing, review, approval, GMP review of batch records. Will be in a
cubical environment and very fast paced and can be loud. Must have
1 year experience in GMP Laws (Good Manufacturing Practices).
Prefer batch record review experience. Must be proficient in use of
computers and Microsoft Office. Education: High school or 2-year
degree
Keywords: Abacus, Cherry Hill , Quality Assurance Document Control, Other , Philadelphia, New Jersey
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