Sr. Quality Assurance Specialist

Summary :

We're in search of a Senior Quality Assurance Specialist to work on innovative aesthetic, therapeutic and financial technology offerings, setting a new standard in healthcare. With experience in technical writing and authoring of quality system records such as laboratory investigations, deviations, CAPA, and change controls pertaining to operational functions supported by Quality Systems & Compliance (e.g., Quality Control)

Here are some of the specific details :

Job Title : Quality Assurance Specialist IV

Location : Newark, CA

Duration : 06 Months contract (with possibility of extension)

Status : Onsite

Job Description : Summary :

Client is a commercial stage biotechnology company focused on innovative aesthetic, therapeutic and financial technology offerings, setting a new standard in healthcare. The Specialist IV provides compliance support or oversight for operational functions at Client. This includes technical writing and authoring of quality system records such as laboratory investigations, deviations, CAPA, and change controls pertaining to operational functions supported by Quality Systems & Compliance (e.g., Quality Control). Conducts investigations for Laboratory Investigation Reports (LIR) and deviations via effective root cause analysis. Monitors completion of the quality system records and provides escalation to management, as needed. Generates and analyzes metrics for operational activities, including but not limited to laboratory investigations and invalid assays and other laboratory operation parameters as appropriate. Authors and / or revises other controlled documents such as procedures, methods, work instructions, protocols, and reports as applicable. Ensures personnel compliance of corresponding training programs for supported operational functions.

• Provide technical writing in support of operational functions, such as Quality Control (QC).
• Responsible for authoring Out of Specification (OOS) and anomalous event laboratory investigations, deviations, CAPA, and change controls.
• Perform risk analysis as needed to determine severity, likelihood of recurrence when triaging events and / or conducting investigations.
• Conduct investigations thoroughly for OOS events according to the phase-based approach per FDA and Annex guidelines.
• Investigate deviations to identify root cause and contributing factors and in parallel assess impact to patients, product quality, data integrity, validated state, and regulatory compliance.
• Identify and develop relevant and effective CAPA.
• Address impact to systems, processes, product, and any regulatory requirements when authoring change controls.
• Prioritize and monitor completion of lab investigations, deviations, CAPA, and change controls.
• Maintain expected standards with concise technical writing using correct grammar, detailed and accurate information, to be completed within established timelines.
• Generate and analyze metrics as applicable.
• Manage and author change controls related to qualification, modification, and / or decommissioning of equipment.
• Possess a strong understanding of data integrity principles.
• Ensure compliance of personnel with corresponding training program(s).

WORK ENVIRONMENT and PHSYICAL DEMANDS :

We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. Client does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.

Skills : EXPERIENCE :

PREFERRED ADDITIONAL SKILLS (I.E., COMPUTER) :

Keywords : Education :

Skills and Experience :

Required Skills :

Additional Skills :

Minimum Degree Required : Bachelor's Degree Certifications & Licenses :

CAPA

Let me know if you are interested in this job and / or if you can assist us by referring someone who is interested in this job, since we offer the lucrative referral bonuses.

A reasonable, good faith estimate of the minimum and maximum for this position is $60-$65 / hour

Benefits will also be available and details are available at the following link : Harvey Nash Benefits

I am looking forward to speaking with you today.

About us :

Harvey Nash is a national, full-service talent management firm specializing in technology positions. Our company was founded with a mission to serve as the talent partner of choice for the information technology industry.

Our company vision has led us to incredible growth and success in a relatively short period of time and continues to guide us today. We are committed to operating with the highest possible standards of honesty, integrity, and a passionate commitment to our clients, consultants, and employees.

We are part of Nash Squared Group, a global professional services organization with over forty offices worldwide.

For more information, please visit us at

Thanks & Regards,

Raj Kumar. Ch

Sr. IT Recruiter

732) 279-4244

Raj.kumar@harveynash.com

Salary : $60 - $65