Quality Assurance Quality Control Jobs in San Diego, California

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.

Sekisui Diagnostics offers a competitive compensation.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

To be successful in this role

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.

Experience using basic laboratory equipment; knowledge of safe laboratory procedures.

Hands-on experience in a pharmaceutical, biotech, drug manufacturing, or academic environment is required, with knowledge of clean room practices being essential.

Six (6) years of relevant experience or a Bachelor's degree in a related field plus two (2) years of related/relevant experience.

Working knowledge of research function. Knowledge of test methods used to test cell therapy products or similar characterization assays.

Skills to communicate complex information in a clear and concise manner both verbally and in writing.

Working skills in analysis and consultation. Strong analytical and critical thinking skills, with the ability to quickly analyze problems.

Specified Requirements: Completed the course entitled “Construction Quality Management (CQM)

Forward resumes and applications by fax: 619-298-0276, or email to [email protected] or mailed:

2424 Congress St., San Diego, CA 92110

Salary: $105,000.00 to $140,000.00 /year

Soltek Pacific Construction Company is an Equal Opportunity/Affirmative Action Employer.

Minimum of 1 or more years of experience in quality inspection or related functions

Experience working in contract manufacturing preferred

Experience in mechanical inspection to ANSI standards

Previous experience with ISO9001 and AS9100

Good analytical and problem solving skills, as well as a keen attention to detail

Strong interpersonal and teamwork skills are necessary to enable individual to work with all positions and personalities

Preferred Qualifications – Education and Experience

Other projects or responsibilities as may be required.

BS with> 5 years of laboratory experience; minimum 3 years performing flow cytometry assays (> 4 color)

Proven track record of knowledge of immunological techniques and ability to troubleshoot with minimal supervision

Excellent organization, communication, documentation and problem-solving skills

Industry experience > 3 years ideally with product development or manufacturing experience

Strong attention to detail, good organizational skills, and the ability to prioritize changing situations

Experience or background with composite materials is a plus

Experience with first-article inspection, material testing, and nonconformance processing

Good interpersonal, written, and verbal communication skills to drive tasks to completion

Working knowledge of Microsoft Office Suite

Provides engineering support for inspection, testing, and Quality related functions

Knowledge of ICH method qualification guidelines and GDP required

Workup, review, and delivery of method feasibility and method qualification results

Provide written protocols for method qualifications and written method qualification reports

Bachelor's Degree in Biology, Biochemistry, Chemistry, or a related science required with 3-5 years of relevant experience

Proficient knowledge of United States Pharmacopeia standards in relation to Microbiological testing

Computer skills (Database software, Microsoft Office Suite)

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.

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.

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

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

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

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.

·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