QA Document Control Specialist // $58/hr. on W2
Hello,I'm a recruiting consultant with Artech and I'm hoping I can help you find the perfect next opportunity for your career goals.
You very well could be happy in your present role, but might be looking for a more challenging project or maybe you want to explore opportunities outside your comfort zone.
I am currently recruiting for a QA Document Control Specialist for one of the largest Pharmaceutical companies in the US.
Below are the specs for the role:
Job Title:
QA Document Control Specialist Location:
Bothell, WADuration:
12
Months (Strong extension possibility)Pay Rate:
$58/hr.
on W2Shift:
Tuesday-Saturday 2 pm -10:
30 pm
Job Description:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
Education:
Bachelor's degree or equivalentExperience Basic
Qualifications:
o Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environmento Strong communication and customer service skills.
o Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principleso Strong computer skills with MS Office (e.
g.
Word, Adobe, Visio and Excel) and with Quality Systems (e.
g.
Document Management System, Quality Management System)o Must demonstrate the following behaviors consistently:
Innovative, proactive, and resourceful; committed to quality and continuous improvemento Able to prioritize, manage time well, multi-task, and troubleshoot effectivelyo Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverableso Possess project management skills.
o Experience interacting with FDA or other regulatory agencies strongly preferredo Strong knowledge of cGMPs and domestic regulatory requirementso Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.
)o Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal networko Some labeling experience strongly preferredDUTIES AND
Responsibilities:
Primary responsibilities include:
o Issuing production batch records, labels, and other controlled documents to support manufacturing operationso Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
o Assist with managing the Document Center Archive roomo Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and and releasing documents to an effective stateo May write and revise document control procedures including participating in the development and roll-out of document control toolso Follow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requestso Assist with cross-training of Document Control personnel and customers to ensure adherence with procedureso Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the siteo Support internal and external audits and regulatory inspections.
This may require data gathering, interviewing or escorting auditors during the audit.
Assist with document retrieval /organization support during regulatory inspectionso Perform Document Control metric reporting and analysis for the local site data.
This may require the use of relational databases and reporting tools to collate and analyze quality datao Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholder.
Recommended Skills Adobe Business Process Improvement Certified Global Meeting Planner Communication Creativity Customer Service Estimated Salary: $20 to $28 per hour based on qualifications.
You very well could be happy in your present role, but might be looking for a more challenging project or maybe you want to explore opportunities outside your comfort zone.
I am currently recruiting for a QA Document Control Specialist for one of the largest Pharmaceutical companies in the US.
Below are the specs for the role:
Job Title:
QA Document Control Specialist Location:
Bothell, WADuration:
12
Months (Strong extension possibility)Pay Rate:
$58/hr.
on W2Shift:
Tuesday-Saturday 2 pm -10:
30 pm
Job Description:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
Education:
Bachelor's degree or equivalentExperience Basic
Qualifications:
o Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environmento Strong communication and customer service skills.
o Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principleso Strong computer skills with MS Office (e.
g.
Word, Adobe, Visio and Excel) and with Quality Systems (e.
g.
Document Management System, Quality Management System)o Must demonstrate the following behaviors consistently:
Innovative, proactive, and resourceful; committed to quality and continuous improvemento Able to prioritize, manage time well, multi-task, and troubleshoot effectivelyo Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverableso Possess project management skills.
o Experience interacting with FDA or other regulatory agencies strongly preferredo Strong knowledge of cGMPs and domestic regulatory requirementso Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.
)o Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal networko Some labeling experience strongly preferredDUTIES AND
Responsibilities:
Primary responsibilities include:
o Issuing production batch records, labels, and other controlled documents to support manufacturing operationso Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
o Assist with managing the Document Center Archive roomo Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and and releasing documents to an effective stateo May write and revise document control procedures including participating in the development and roll-out of document control toolso Follow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requestso Assist with cross-training of Document Control personnel and customers to ensure adherence with procedureso Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the siteo Support internal and external audits and regulatory inspections.
This may require data gathering, interviewing or escorting auditors during the audit.
Assist with document retrieval /organization support during regulatory inspectionso Perform Document Control metric reporting and analysis for the local site data.
This may require the use of relational databases and reporting tools to collate and analyze quality datao Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholder.
Recommended Skills Adobe Business Process Improvement Certified Global Meeting Planner Communication Creativity Customer Service Estimated Salary: $20 to $28 per hour based on qualifications.
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