Quality Associate I

One of our Bioscience clients is looking for a Quality Associate to join their team in Duarte, CA.

The Quality Associate I is responsible for production compliance and support for all departments at the company within the regulated environment as applicable to state and federal regulation (i.e. FDA).

Job Description:
• Understand quality procedures, safety procedures and cGXP procedures and systems.
• Review in-process batch records/manufacturing run sheets and COAs to support product release.
• Conduct cross functional training for any applicable departments.
• Identify and assess regulatory and quality risks in production and manufacturing according to applicable regulations and company quality practices. This could include on floor observations and support. Communicate and report product quality problems in the production lines or anywhere in the facility to appropriate personnel.
• As needed, write and provide technical review for observation reports (OR) and nonconformance (NC) investigations and determine effective corrective actions.
• Support investigations pertaining to lookbacks and product complaints.
• May work with suppliers on supplier issues, and completion of supplier corrective action report (SCAR)
• Make interpretations of data generated and communicating the significance of these results to Quality Management.
• Support manufacturing teams in the investigation and prevention of nonconformance issues.
• Identify and update procedures that require corrections or updates.
• Review and may approve the following records in the quality system: CPAs, CSRs, and ORs.
• Initiate SCARs as needed.
• Complete continuous improvement projects as assigned.
• Attend daily meetings. This may include taking meeting minutes/ notes and communicating information to Quality Management.
• Perform bottle sampling per Acceptable Quality Limits (AQL) as needed.
• Perform product bottle inspection as needed.
• Provide training to co-workers regarding Quality Associate and Quality Inspector responsibilities.
• Release raw materials per the material specification (MS).
• Provide support to all departments requiring assistance. This may include Research and Development (R&D) requests that pertain to batch records or product movement between facilities.
• Interface with the Manufacturing Enterprise System and conduct Quality tasks.
• Quarantine materials and review for manufacturing release.
• Support with internal/external GMP audits.
• Update and maintain metrics related to fulfillment.
• Perform EHS and GMP walk-throughs to ensure facility compliance.
• Act as a liaison between manufacturing and Quality to help trouble-shoot quality related issues.
• Daily Production and QC floor support.

Pay Range: $25/hr - $35/hr

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

• B.A./B.S. Degree in Biology, Biochemistry, Chemistry, or other related sciences with 1-3 years of experience in a regulated manufacturing environment or 8-10
years of relevant experience in a regulated manufacturing environment.
• Knowledgeable with FDA regulations and cGMP.
• Strong written communication skills. Must be able to clearly document observation deviations.
• Excellent interpersonal skills to maintain partnerships between Quality and all departments to ensure the lines of communication are professional and congenial.
• Must effectively communicate with all levels of personnel.
• Must be flexible with hours to accommodate production/business needs.
• Ability to work in a cold environment for a limited period of time.

• Working experience in clean room environment.
• Computer skills (i.e. MS Word, Excel, PowerPoint, etc.).
• Effective presentation skills.
• Working knowledge of continuous improvement, a plus.
• Knowledge of FDA 21 CFR 106, 107, 110, 117 and ICH is highly desired.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.