Cytokinetics
Contract - QA Document Control Specialist
Cytokinetics, San Francisco, California, United States, 94199
Overview
Contract - QA Document Control Specialist at Cytokinetics. Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for diseases with compromised cardiac muscle performance. This role ensures documents submitted to Document Control are formatted according to requirements and processed in the Quality Management System (QMS). They collaborate with cross-functional groups and assist with management of records throughout the document lifecycle, track training and communicate due training and overdue training. Responsibilities
Manage and process controlled documents in the electronic document management system throughout their lifecycle (e.g. SOPs, Policies, Work Instructions, Forms) Perform formatting and editing of controlled documents to ensure consistency and compliance prior to routing for document approvals. Provide guidance and training to document owners/authors, collaborators, and approvers throughout the document management lifecycle. Track training, prompting employees to complete training on time. Qualifications
Minimum of 5 yrs of experience performing Document Control & Training. Knowledge of Veeva Vault Quality Docs and Training required. Must be highly organized with a strong attention to detail and comfortable working in a fast-paced environment. Must have advanced skills in MS Office Suite, particularly in Word document processing and formatting. Experience writing, reviewing and editing SOPs, as well as other document types. Ability to work in a collaborative team environment is essential, with a customer-focused approach. Must have strong interpersonal and communication skills. Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems preferred. Pay Range
In the U.S., the hiring pay range for fully qualified candidates is $56.25 - $93.75 an hour. The base pay actually offered will take into account internal equity and may vary depending on geographic region, job-related knowledge, skills, and experience among other factors. Note:
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our GDPR policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning:
Fraud warnings about Cytokinetics postings exist; legitimate offers will come from Cytokinetics.com after a formal interview process. Authenticity checks:
We do not conduct interviews via non-standard text messaging, never request banking details before an official offer, never ask you to purchase equipment during interviewing, and contact talentacquisition@cytokinetics.com if unsure about authenticity. Website:
www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer
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Contract - QA Document Control Specialist at Cytokinetics. Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for diseases with compromised cardiac muscle performance. This role ensures documents submitted to Document Control are formatted according to requirements and processed in the Quality Management System (QMS). They collaborate with cross-functional groups and assist with management of records throughout the document lifecycle, track training and communicate due training and overdue training. Responsibilities
Manage and process controlled documents in the electronic document management system throughout their lifecycle (e.g. SOPs, Policies, Work Instructions, Forms) Perform formatting and editing of controlled documents to ensure consistency and compliance prior to routing for document approvals. Provide guidance and training to document owners/authors, collaborators, and approvers throughout the document management lifecycle. Track training, prompting employees to complete training on time. Qualifications
Minimum of 5 yrs of experience performing Document Control & Training. Knowledge of Veeva Vault Quality Docs and Training required. Must be highly organized with a strong attention to detail and comfortable working in a fast-paced environment. Must have advanced skills in MS Office Suite, particularly in Word document processing and formatting. Experience writing, reviewing and editing SOPs, as well as other document types. Ability to work in a collaborative team environment is essential, with a customer-focused approach. Must have strong interpersonal and communication skills. Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems preferred. Pay Range
In the U.S., the hiring pay range for fully qualified candidates is $56.25 - $93.75 an hour. The base pay actually offered will take into account internal equity and may vary depending on geographic region, job-related knowledge, skills, and experience among other factors. Note:
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our GDPR policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning:
Fraud warnings about Cytokinetics postings exist; legitimate offers will come from Cytokinetics.com after a formal interview process. Authenticity checks:
We do not conduct interviews via non-standard text messaging, never request banking details before an official offer, never ask you to purchase equipment during interviewing, and contact talentacquisition@cytokinetics.com if unsure about authenticity. Website:
www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer
#J-18808-Ljbffr