Job description

Title: Quality Assurance Contractor
Location: 50% on-site Brisbane, CA

Candidate will need to be onsite in Brisbane a couple days a week to start

6 months Role with a possible extension

Summary Description
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Quality Assurance Contractor located at our Brisbane, California office. The individual will be responsible for supporting the overall operation, maintenance, and continual improvement of the organization’s GxP electronic Document Management System (eDMS) and Learning Management System (eLMS) in compliance with appropriate regulations and guidelines. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.

Essential Duties and Responsibilities

• Perform Document Control review of GxP controlled documents (Policies/SOPs/Work Instructions, etc). to ensure Myovant GxP document template and style is followed, and appropriate document reviewers and approvers are identified per established requirements.
• Assign training curricula to new and existing employees at the direction of employee managers.
• Support the organization and facilitation of in-person and virtual classroom trainings.
• Provide Document Control and Training support for cross-functional team projects.
• Support record management activities.
• Assist with process improvement initiatives.
• Participate in developing and improving Standard Operating Procedures (SOPs) and Work Instructions pertaining to Document Control and Training processes.
• Assist with other Quality Systems and Compliance assignments.

Core Competencies

• Demonstrate communication and collaboration skills with an ability to effectively manage and influence stakeholders in a matrix environment.
• Exercise good judgment and make decisions that are appropriate for the organization.
• Results-driven, take initiative and ownership to accomplish work.
• Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment

Strive for continuous improvement and embrace innovative ideas in daily work.

• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, integrity, and trust building behavior.
• Must have excellent customer-service orientation, high degree of professionalism, ability to work with limited direction and work successfully within a cross-functional team/partnership environment.
• Ability to multi-task and shift priorities quickly while working under tight deadlines.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Strong PC experience and proficiency in MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) a plus.
• Good organizational skills with a strong attention to detail and accuracy.
• Excellent written and verbal communication skills to build trust and respect within the organization.

REQUIREMENTS (Education and Experience)

• Bachelor’s degree in scientific discipline or related field preferred.
• At least 3-5 years of pharmaceutical experience in a GMP environment administering Document Control systems and Training Compliance programs.
• Strong working knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs), as well as Quality System regulations and guidance documents.
• Experience with Veeva eDMS and LMS a plus.

Additional Information-
Position is Hybrid- Candidate will need to be onsite in Brisbane a couple days a week to start. There is an Archive room that they will need to help go through and clean up.
Contract is 6 months with a possible extension

The well-being and safety of our employees is our top priority. Requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based). Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.

Job Type: Contract

Pay: $30.05 - $36.73 per hour

Benefits:

• Dental insurance
• Health insurance

Schedule:

• 8 hour shift
• Monday to Friday

COVID-19 considerations:
The client does not have COVID precaution rules for remote workers.

Ability to commute/relocate:

• Brisbane, CA 94005: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• pharmaceutical experience in a GMP environment: 3 years (Required)
• Document Control systems and Training Compliance programs: 3 years (Required)
• Good Manufacturing Practices (GMPs): 3 years (Required)
• Good Laboratory Practices (GLPs): 3 years (Required)
• Quality System regulations and guidance documents: 3 years (Required)

Work Location: One location

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