Quality Assurance Specialist - Documentation Support - Pioneer Data Systems
Bothell, WA 98021
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in Bothell, WA is currently looking for a Quality Assurance Specialist to join their expanding team.
Job Title: Quality Assurance Specialist / GMP Documentation (Pharma Manufacturing)
Duration: 12 months contract, extendable up to 36 months
Location: Bothell, WA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Quality Assurance Specialist - Documentation Support
Summary:
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.
Our science and risk-based compliant quality culture is flexible, innovative and customer oriented.
Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
In your role, you have the all-important task of preparation and review of required procedures, documentation, and retention practices, supporting inspections, and supporting ongoing continuous improvement and compliance efforts.
You will be relied on to support globally across PharmSci, partner lines, and client Global Supply to align goals and support the implementation of effective quality system solutions.
Your skills will help you collaborate and implement practices and gain efficiencies throughout quality procedures and R&D documentation.
Your knowledge and skills will contribute towards the goals and objectives of the team.
Your focus and ability to meet team targets will help in completing important deliverables on time.
Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.
It is your dedication and hard work that will make it possible for Pharmaceutical's customers and patients to receive the medicines they need, when they need them.
Responsibilities:
Perform procedural administration activities within the Global Documentation Management System
Partner with PharmSci business lines in the development, implementation, and management of their procedures, documentation and records
Support the management of Active libraries and other documentation systems (e.g. Document Long Term Storage) for PharmSci to ensure adequate control of physical and electronic records, including logbook issuance and reconciliation
Manage the inventory of records within the Central Index of Company Records (CICR) system to support the creation, management, retention, and disposal of company records and information
Partner with the Enterprise Records and Information Management (eRIM) team to ensure alignment with client record retention policies and legal holds
Partner with the off-site Pharmaceutical Record Service Centers (PRSC) to manage the lifecycle of company records and to ensure robust process for retrieval of records in support of audits and inspections
Provide document technical writing, editing, and design support to other team members and supported site departments
Work closely with project teams to ensure that documents are accurate, internally consistent, and meet intended purpose. Prepare documents in accordance with internal standards and external regulatory guidelines
Support equipment change controls, management of calibration/PM schedules, and coordination of associated documentation
Qualifications:
High school diploma or GED required
A minimum of 1+ years of relevant experience
Understanding of cGMP, Data Integrity, and ALCOA principles
Strong organizational and communication skills
Strongly skilled in word processing and document formatting; very experienced in Microsoft Office applications (Word, Excel, PowerPoint, Visio)
Relevant pharmaceutical experience preferred
Demonstrated technical writing experience is desirable
Strong project management skills preferred
Location:
This is a fully onsite role in Chesterfield, MO
Our client, a world-leading Pharmaceutical Company in Bothell, WA is currently looking for a Quality Assurance Specialist to join their expanding team.
Job Title: Quality Assurance Specialist / GMP Documentation (Pharma Manufacturing)
Duration: 12 months contract, extendable up to 36 months
Location: Bothell, WA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Quality Assurance Specialist - Documentation Support
Summary:
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.
Our science and risk-based compliant quality culture is flexible, innovative and customer oriented.
Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
In your role, you have the all-important task of preparation and review of required procedures, documentation, and retention practices, supporting inspections, and supporting ongoing continuous improvement and compliance efforts.
You will be relied on to support globally across PharmSci, partner lines, and client Global Supply to align goals and support the implementation of effective quality system solutions.
Your skills will help you collaborate and implement practices and gain efficiencies throughout quality procedures and R&D documentation.
Your knowledge and skills will contribute towards the goals and objectives of the team.
Your focus and ability to meet team targets will help in completing important deliverables on time.
Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.
It is your dedication and hard work that will make it possible for Pharmaceutical's customers and patients to receive the medicines they need, when they need them.
Responsibilities:
Perform procedural administration activities within the Global Documentation Management System
Partner with PharmSci business lines in the development, implementation, and management of their procedures, documentation and records
Support the management of Active libraries and other documentation systems (e.g. Document Long Term Storage) for PharmSci to ensure adequate control of physical and electronic records, including logbook issuance and reconciliation
Manage the inventory of records within the Central Index of Company Records (CICR) system to support the creation, management, retention, and disposal of company records and information
Partner with the Enterprise Records and Information Management (eRIM) team to ensure alignment with client record retention policies and legal holds
Partner with the off-site Pharmaceutical Record Service Centers (PRSC) to manage the lifecycle of company records and to ensure robust process for retrieval of records in support of audits and inspections
Provide document technical writing, editing, and design support to other team members and supported site departments
Work closely with project teams to ensure that documents are accurate, internally consistent, and meet intended purpose. Prepare documents in accordance with internal standards and external regulatory guidelines
Support equipment change controls, management of calibration/PM schedules, and coordination of associated documentation
Qualifications:
High school diploma or GED required
A minimum of 1+ years of relevant experience
Understanding of cGMP, Data Integrity, and ALCOA principles
Strong organizational and communication skills
Strongly skilled in word processing and document formatting; very experienced in Microsoft Office applications (Word, Excel, PowerPoint, Visio)
Relevant pharmaceutical experience preferred
Demonstrated technical writing experience is desirable
Strong project management skills preferred
Location:
This is a fully onsite role in Chesterfield, MO
Source : Pioneer Data Systems