Senior Quality Assurance Associate - Gallatin, United States - SPECTRAFORCE

SPECTRAFORCE Gallatin, United States

3 weeks ago

Description

Job Title: Senior Quality Assurance Associate

Location: Thousand Oaks, CA, 91320

Duration: 7 months

Description:

FULLY ONSITE

DAY & SWING SHIFT

This position supports Client's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations and CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Day to Day Responsibilities:

This role supports Client's Quality Assurance program providing daily oversight of Drug Substance manufacturing facilities at Client Thousand Oaks. Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems.

Duties include electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of non-conformances and CAPAs. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

Preferred Qualifications:

•Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.

• Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices.

Also, ability to make Quality based decisions in order to ensure compliance.

• Experience managing projects through to completion & meeting timelines.

• Evaluating documentation and operations according to company procedures.

• Experience working with Quality Systems, Strong organizational skills and ability to manage multiple tasks at one time/ Effective communication skills (both written and verbal)

• Demonstrated ability to work as both a team player and independently

• Display leadership attributes and drive improvement initiatives.

• Solid understanding and application of aseptic behaviors and principles

CPRA: Notice to California Applicants: SPECTRAFORCE is committed to complying with the California Privacy Rights Act ("CPRA") effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting

About Us: Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of "human connection," defined by our branding attitude of NEWJOBPHORIA, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

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