Documentation Assistant II (Pharma )IA
Documentation Assistant II
COMPANY: A leading pharmaceutical company headquartered in
LOCATION: Fort Dodge, IA
DESCRIPTION: The purpose of this position is for the coordination of
documentation systems to ensure compliance, control,
accountability, traceability, communication, retrieval and
archiving of critical documentation throughout the lifecycle of
the documents, including routing and issuance. This position
will support maintenance of databases, accuracy and tracking of
SOP's, Form revisions, Unusual occurrences, CAPA items, OOP
revisions and shop packets. This position will also assist
Production personnel with administrative activities such as
preparation of batch records, willing of shop packets, release
paperwork for antigen/seeds and other Production records as
needed. This position will be responsible for all seed usage and
paper trail requirements (including audits, inventories and OOP
Prepare, route and track revisions for SOP's and controlled
forms. Monitors batch records for errors and applies
improvements to those forms through revisions to reduce
Assemble folders with required batch records and support
documents for each lot produced. Assemble folders for all
cleaning documentation, autoclave runs; filter testing,
bioreactor and tank logs.
Prepare shop packets as needed and enter data into MAPICS
after completion of process. Cross check shop packets against
batch records to reduce inventory errors and usage errors
Tracks and prepares supporting documentation for Unusual
Occurrences and CAPA items.
Accountability and transfer to QA archives of all monthly
cleaning logs, equipment logs, filter integrity testing to ensure
compliance with routine activities in Production.
Maintain database for harvest results and provides trending
Compile and transfer completed records, logs and seed records
to Doc Center for storage and archiving. Ensure integrity of
seed traceability documentation.
Assembles and monitors progress of test reports for timely
release of antigens. Assembles test reports and is a designee
for release of batches.
Responsible for the control of seed inventory and retrieval,
archiving of cell culture and seed records for QA review.
Responsible for the compilation and tracking of OOP and
Registration changes/revisions that affect APUII
EXPERIENCE: At least 5 years documentation experience in Pharmaceutical or
Biological manufacturing environment.
Must have proficient computer skills, specific experience with
word processing, spreadsheets and database management.
Must be detailed oriented and able to perform with minimal
General understanding of biological production processes.
Ability to handle several projects in quick-paced environment
while maintaining traceability of work performed and
communication to other departments.
Ability to draft portions of technical documents and strong
Must exhibit an excellent communication and written skill set.
Demonstrated ability to work in a team environment.
Satisfactory performance record.
EDUCATION: High School diploma or equivalent; College Degree preferred