Clinical-Scientific - Quality Assurance Specialist - 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:
Why Patients Need You
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.
What You Will Achieve
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 Pharmaceutical 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.
How You Will Achieve It
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 Pharmaceutical 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
Must-Have
1+ years of 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).
Nice-to-Have
Relevant pharmaceutical experience.
Demonstrated technical writing experience is desirable.
Strong project management skills.
Physical/Mental Requirements
Mental agility to handle a broad scope of different types of quality assurance work (e.g. reviewing documentation focus, communication 1:1 and with larger groups).
Ability to independently problem solve and make recommendations for solutions.
Role is primarily office-sitting, standing, walking, and bending.
This may be inclusive of leading/participating in Webex.
Interview Process:
Phone Screen: (Teams Bridge Camera off)
Teams (Camera on)
Onsite: Bothell, WA
Minimum Education:
HS
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:
Why Patients Need You
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.
What You Will Achieve
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 Pharmaceutical 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.
How You Will Achieve It
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 Pharmaceutical 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
Must-Have
1+ years of 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).
Nice-to-Have
Relevant pharmaceutical experience.
Demonstrated technical writing experience is desirable.
Strong project management skills.
Physical/Mental Requirements
Mental agility to handle a broad scope of different types of quality assurance work (e.g. reviewing documentation focus, communication 1:1 and with larger groups).
Ability to independently problem solve and make recommendations for solutions.
Role is primarily office-sitting, standing, walking, and bending.
This may be inclusive of leading/participating in Webex.
Interview Process:
Phone Screen: (Teams Bridge Camera off)
Teams (Camera on)
Onsite: Bothell, WA
Minimum Education:
HS
Source : Pioneer Data Systems