Planet Pharma
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http://www.theplanetgroup.com
http://www.theplanetgroup.com
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QA Associate II
6701 Kaiser Drive Fremont, CA 94555 US
Posted: 05/24/2023
2023-05-24
2023-07-07
Employment Type:
Contract
Job Category: Scientific
Job Number: 564006
Is job remote?: No
Country: United States
Job Description
Target PR Range: MARKET RATE
*Depending on experience
The Senior Associate will provide general guidance and support DMS activities. Routinely performs administrative tasks to support the creation, revision, and retirement of controlled documents according to Standard Operating Procedures to support current Good Manufacturing Practices operations.
Participates in project teams to meet time lines.
Support the Electronic Document Management System (EDMS) for Fremont. Provides 2nd level business support and issue resolution, documentation and configuration, delivering workshops with/for Key Users, and facilitating training. Supports the management and audit of vital records and electronic records, and provides records management system support to record owners.
Support continuous improvement in business processes and records themselves.
Manage controlled documents for the Fremont site, to ensure correct implementation, access, and upkeep of documents. Acts as key point of contact for users, and provides customer support and troubleshooting for creation and editing of documents and workflows. Distributes document links to the appropriate viewers.
Support training relating to DMS processes, templates and electronic systems to Fremont staff. Provides local business administrators with information about the appropriate roles for document signatories.
Support with focusing on DMS continuous improvements.
Support documenting the required configuration according to global standards, configuring the application according to specification and, where appropriate, testing the configuration prior to use in Production.
Support technical actions required to make local configuration support current business needs for document management.
Administers and processes records within the B4 High Density Fileroom.
Provides inspection/audit support for retrieval and archive of records; performs annual audit of records; provides customer support for all information relating to records and document management; and ensures records are archived in accordance with local archival standards.
May participate in regularly scheduled international user-based teleconferences and face to face meetings. Meeting regularly with user community representatives (one-on-one and in groups) to identify particular problem areas and determine solutions.
Provides input into content on the EDMS.
Support technical actions required to make local configuration support current business needs for document management.
DMS best practices within GXP regulations. Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to DMS quality systems. Issuance and maintenance of controlled documents, implementation, access, and upkeep of documents.
• Analytical Thinking - demonstrating
• Business and Technical Competence - demonstrating
• Planning and organizing - demonstrating
• Communication - demonstrating
• Creativity and Innovation - demonstrating
• Delivering Results - demonstrating
• Persistence/Energy - demonstrating
High School Diploma or equivalent with 5 years of progressive experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience within DMS and Quality System.
Associates degree or or biotechnology vocational training with 3 years closely related experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience and Quality Systems.
Bachelor’s degree, preferably in a science or engineering related field, and a minimum of 1 year closely related experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience and Quality Systems.
• Knowledge and ability to judge what information should be passed on to different levels of management or organizational units.
• Demonstrate analytical skills and a systematic approach to problem-solving, with an emphasis on process development and optimization, not just system maintenance.
• Demonstrate ability to deliver solutions in a timely fashion under rapidly changing conditions.
• Proficiency in MS Office Suite
• Must work effectively within teams with rapidly changing priorities.
• Possesses initiative and is proactive.
*Depending on experience
The Senior Associate will provide general guidance and support DMS activities. Routinely performs administrative tasks to support the creation, revision, and retirement of controlled documents according to Standard Operating Procedures to support current Good Manufacturing Practices operations.
Participates in project teams to meet time lines.
Support the Electronic Document Management System (EDMS) for Fremont. Provides 2nd level business support and issue resolution, documentation and configuration, delivering workshops with/for Key Users, and facilitating training. Supports the management and audit of vital records and electronic records, and provides records management system support to record owners.
Support continuous improvement in business processes and records themselves.
Manage controlled documents for the Fremont site, to ensure correct implementation, access, and upkeep of documents. Acts as key point of contact for users, and provides customer support and troubleshooting for creation and editing of documents and workflows. Distributes document links to the appropriate viewers.
Support training relating to DMS processes, templates and electronic systems to Fremont staff. Provides local business administrators with information about the appropriate roles for document signatories.
Support with focusing on DMS continuous improvements.
Support documenting the required configuration according to global standards, configuring the application according to specification and, where appropriate, testing the configuration prior to use in Production.
Support technical actions required to make local configuration support current business needs for document management.
Administers and processes records within the B4 High Density Fileroom.
Provides inspection/audit support for retrieval and archive of records; performs annual audit of records; provides customer support for all information relating to records and document management; and ensures records are archived in accordance with local archival standards.
May participate in regularly scheduled international user-based teleconferences and face to face meetings. Meeting regularly with user community representatives (one-on-one and in groups) to identify particular problem areas and determine solutions.
Provides input into content on the EDMS.
Support technical actions required to make local configuration support current business needs for document management.
DMS best practices within GXP regulations. Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to DMS quality systems. Issuance and maintenance of controlled documents, implementation, access, and upkeep of documents.
• Analytical Thinking - demonstrating
• Business and Technical Competence - demonstrating
• Planning and organizing - demonstrating
• Communication - demonstrating
• Creativity and Innovation - demonstrating
• Delivering Results - demonstrating
• Persistence/Energy - demonstrating
High School Diploma or equivalent with 5 years of progressive experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience within DMS and Quality System.
Associates degree or or biotechnology vocational training with 3 years closely related experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience and Quality Systems.
Bachelor’s degree, preferably in a science or engineering related field, and a minimum of 1 year closely related experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience and Quality Systems.
• Knowledge and ability to judge what information should be passed on to different levels of management or organizational units.
• Demonstrate analytical skills and a systematic approach to problem-solving, with an emphasis on process development and optimization, not just system maintenance.
• Demonstrate ability to deliver solutions in a timely fashion under rapidly changing conditions.
• Proficiency in MS Office Suite
• Must work effectively within teams with rapidly changing priorities.
• Possesses initiative and is proactive.
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