Quality Assurance Quality Control Jobs in San Joaquin, California

Collaborate with cross-functional teams, including development, product management, and customer support, to drive quality initiatives.

Present regular quality status reports to senior management, highlighting areas of concern and improvement opportunities.

Recruit, mentor, and manage a high-performing QA team, providing coaching and professional development opportunities.

Foster a collaborative and inclusive team environment that encourages open communication and knowledge sharing.

Experience with test automation tools and frameworks.

Excellent communication, leadership, and interpersonal skills.

A minimum of 1year experience in a FDA or ISO/GMP regulated production environment

Effective written and communication skills

Is proficient at operating instrumentation, including cytometers.

Works on problems of diverse scope where analysis of situations or data requires evaluation of identifiable factors.

Follow standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

Participate and support legacy and new product validation activities.

Coordinate with customers and licensors on compliance requirement, ensure product and facilities meet compliance requirements.

·Monitor and execute FDA regulations and requirements for Ashtel and contract manufactures facilities and products.

·Manage FDA related documentations and records.

·Actively manage improvement programs to create efficiency to the organization.

·Manage, mentor, and coach the team, fostering a collaborative environment.

·Lead and oversee sourcing efforts for existing and new products/categories with both current and prospective suppliers.

Strong knowledge of mathematics, data analysis, and statistical methods. Good technical and IT skills.

Oversee that FDA, EU, and ISO standard requirements are documented to maintain compliance for the personal care industry.

Establishing, coordinating & managing external analytical capabilities/partners to ensure timely assessment of product quality.

Strong communication, leadership, process development, training, organization, and prioritization skills.

Strong attention to detail, observation, organizational, and leadership skills.

In-depth knowledge of quality control procedures, equipment, and industry standards.

Report any and all issues immediately to upper management

Essential duties and responsibilities to include but not limited to:

Ensures that all cleaning & environmental monitoring practices are followed

Ensures that calibration of all equipment in the facility is maintained

Ensure routine preventive maintenance is completed on all equipment, INCLUDING the water system

Investigate all issues according to non-conformance procedure

Sekisui Diagnostics offers a competitive compensation.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

To be successful in this role

Thorough knowledge of microbiological analytical methods, and compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.

Familiarities with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological-related methods.

Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).

Prior experience in a QC microbiology testing laboratory.

Demonstrable experience with cGMP and regulatory compliance (FDA, EMA, and other international agencies).

Minimum Education bachelor’s degree in microbiology or related science degree or technical field.

Reviews all obtained data to identify trends, reporting positive and/or negative trends to management by generating and reporting KPIs.

Certification and application experience in Preventive Controls, SQF, GMP, and HACCP Plans

Support internal Food Safety audits, as well as manage third-party inspections such as FDA, County, City, Organic, SQF, and customer audits.

Ensure compliance with customer program requirements and specifications.

3 years experience in food safety in a food manufacturing environment preferred.

2 years of supervisory experience

1-2 years’ experience preferred, in a chemistry lab in the pharmaceutical, food, or other closely related industry.

·Other tasks assigned by QC manager.

Ability to read and follow written procedures.

·Physical testing on in-process, finished product and stability samples.

with equipment setting and sample preparation.

·Monitoring and changing chart records.

Leadership, coaching and training skills and experience

Evaluates customers’ requirements to ensure customer satisfaction

Supervisory experience in a quality assurance role in textiles or apparel manufacturing

Demonstrated knowledge and ability to apply Statistical Quality Tools

Essential duties and responsibilities include:

Improves and enforces quality assurance standards, policies and procedures

·Experience in cleaning validation, process validation and supply chain management.

C.) Thorough knowledge of 21 CFR 820.

F.)Experience in USFDA and ISO auditing and ability to lead team to successful audits.

G.) Experience with designing and developing test cases based upon system specifications.

· Minimum 5-7 years of experience in leading company to maintain GMP, ISO and FDA Regulations

4.) Directs and enforces GMP’s, GLP’s, and safety policies.

Minimum of 6+ months of customer experience preferred

Customer service phone experience preferred

Excellent customer services and clear verbal communication skills

Experience with Phone system: YTEL and CRM preferred

Knowledgeable of MS Office: word, excel, outlook

2+ Years’ experience in Debt Settlement or related industry

2+ years of experience in Quality Control.

Excellent problem-solving and communication skills

B.S. in Chemistry, Biology, or related Life Science Field

2+ years in a GMP manufacturing environment

Strong attention to detail and ability to follow procedures

Ability to work well in a team environment

Education, Certification, Licenses & Registrations

Other FDA regulated industry experience in a quality or regulatory department.

Works with QC Supervisor to follow Monster Energy’s quality guidelines, SOP’s etc.

Assist in the remediation of all deviations, variance explanation

Operates with testing instruments (e.g. CIP, HPLC, Water testing.

Oversees the calibration of equipment.

Previous working experience in the lab, sample management, aseptic techniques, and cell culture activities are highly recommended.

Executes QC sample management activities, which include receipt, inventory sample entry, sample distribution, sample label creation, sample coordination/shipment preparation, and disposal.

Performs routine maintenance of laboratory reagents/materials orders and inventory management.

Should be able to manage the workload, meet deadlines, be eager to learn new techniques, and demonstrate good organizational skills.

Basic understanding of Good Laboratory Practices (GLP) with strict adherence to cGMP requirements is essential.

Dependable, able to learn new skills rapidly, and able to work well within the team.

Ability to prioritize multiple responsibilities and meet deadlines

Intermediate PC and MS Office skills

Drives to the post office to pick up mail.

Maintains and organizes the Title Documents room.

Assists in resolving any administrative problems that come up such as supply issues, document assembly/packaging or mail.

Scans, files, and prints documents

Knowledge related to laboratory information management system (LIMS) and electronic lab notebook record keeping (ELN).

Review capabilities of the CDMOs against CARGO’s product and technology requirements and help to develop a tech transfer plan.

Experience with method transfer/qualification/validation, routine testing in QC environment.

THE RIGHT STUFF: Required Experience & Qualifications

Translate analytical technical requirements into executable and compliant manufacturing and quality documents for lead asset and future pipeline products.

Review executed test methods at the CDMO and ensure they meet the requirements of CARGO process and regulatory guidelines.

Experience in the financial services industry, specifically wealth management and/or asset management

Excellent verbal and written skills

Help to develop effective QA processes and procedural documents, and maintain changes accordingly

Create and implement test scenarios and test cases to include both positive and negative unit testing as well as regression review

Conduct test case reviews to ensure scenarios accurately capture business functionality

Identify and create test data needed for execution

SQF certification and audit experience is preferred.

Manage vendor QA submissions for each product to ensure all necessary documentation is received.

Provide technical guidance to vendors to assist with correct interpretation and implementation of the minimum vendor requirements.

Oversee all plant HACCP, pre-requisite quality programs, and all quality/food safety-related programs to meet regulatory and customer requirements

Manage governmental and third-party audit programs

Previous experience in quality assurance/food safety within a food processing environment (preferred in a $5m-$10M revenue facility)

Experience in supplier management and relations, including quality agreement generation and maintenance

Thorough of design control principles and risk management (FMEA and Hazard Analyses)

Demonstrate excellent interpersonal communication skills, which enable you work with multiple BD business units.

Ability to communicate ideas and knowledge effectively and clearly to other individuals, teams and customers.

Quality Engineering experience or 12+ years industry experience (Healthcare/ Pharmaceutical)

Good written and oral communication skills