Associate Quality Assurance Specialist Jobs

• May work with management to update job training matrix.

• May track and report deviation QC trends to management.

• Coordinates and schedules all assigned quality control projects with minor assistance from coworkers and manager.

• Participates in continuing education through self-study, attending training sessions and lectures and meetings.

• Supports safety, quality, and 5S requirements and initiatives.

• Complies with company's procedures and regulatory requirements, as applicable.

Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below)

Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager

Transfer materials between facilities (see lifting requirements below)

Required experience in GMP and FDA regulated environments (ISO 13485:2016preferred)

1 year experience in regulated industry highly desirable

Perform line clearance activities and in-process inspections

Work with Department management to assign personnel and training materials to the appropriate Job Roles/curricula in Veeva

Interact with internal customers at various management levels to provide customer service

Manage GXP central filing system

Support Quality Control data entry processes

Minimum of 1-3 years of experience in a pharmaceutical and/or biotech company.

Advanced computer capabilities including all MS Office products

Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data

Support QA management to ensure product quality and compliance with cGMPs .

Familiar with ISO 9001, FDA QSR requirements

Exceptional written and verbal skills

Typically requires 2 years of related experience.

The estimated pay scale for the Quality Assurance Associate role based in Vista, CA is $23.52 - $35.28/hour depending on experience

Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other bodies.

Masters degree in Business Management or MBA is preferred

Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.

Corporate and GQO requirements, Quality System Regulations and standards.

Minimum of 6+ years' experience in a Medical Device, Pharmaceutical, Bio-Medical/Pharma, or regulated manufacturing environment.

Experience of successfully creating and managing a talented, engaged and performing team is advantageous.

Must possess organizational skills with the ability to use resource materials to manage multiple projects

Reviews customer purchase orders, specification and prints to ensure processing meets all requirements

Experience in diffusion coatings operations and processes/equipment typically used in a coatings-manufacturing environment

Proven ability to combine theoretical training with practical experience in a "hands-on" environment

Excellent written and verbal communication skills

Experience with ISO/AS quality systems

Supports quality source selection and process reviews of suppliers' ability to meet program quality requirements.

1+ years of experience with NCM (Non-Conformance Issues)

1+ years of experience with Manufacturing Execution Systems common image (MESci)

Experience working in a cross functional environment

Collects and verifies data to support the identification of root cause routine problems.

Provides ideas and concepts for corrective action development.

Relevant certifications and/or experience may be substituted in lieu of this requirement

Assist the site QAS in collaborations, including problem-solving and continuous improvement efforts, and communications with the Facility Manager and Operations team.

Assist in the oversight of the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).

Support the site QAS and Facility Manager in aseptic operations compliance (e.g., cleaning, sanitation, organization, etc.)

Support compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.

Assists QAS, Directors, QA and Regional Managers, QA, etc. as necessary.

Supports the maintenance and upkeep of the Quality Management System (QMS).

Manages the review cycle of QA controlled documents to assure practices reflect written procedures.

Knowledge of current GCP regulations preferred.

Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program.

Supports clinical sites and vendors/suppliers.

Supports internal audit program and performance metrics system for continual improvement.

Manage Quality Management Systems, including deviation investigation, CAPA, and minor Change Control.

BA/BS (preferably in Science) or High school diploma with equivalent work experience.

Minimum 2 years of experience in cGMP manufacturing. Previous Quality Assurance experience is preferred.

Conduct meticulous batch record reviews, encompassing Quality Control, manufacturing, packaging, and Quality Assurance records to ensure accuracy and adherence to standards.

Oversee Quality Assurance activities at Contract Manufacturing Organizations (CMOs) involved in the production and packaging of pharmaceutical products.

Collaborate with external partners to identify areas of improvement and ensure compliance with CGMPs and regulatory expectations.

Updates, maintains and improves quality management systems process documents and documentation

Supports during regulatory inspections, audits and Management Reviews

Tracks, reviews and assists in organizing reporting metrics and data for use in continuous improvement and Quality Management System reviews.

A minimum of 3 years of relevant work experience in a GMP environment.

Health Benefits: Medical, Dental, Vision

a minimum of 3 years of relevant work experience in a GMP environment.

80% employer-paid MEDICAL HMO plan

80% employer-paid DENTAL PPO plan

We are in works to add 100% employer-paid Basic Life/AD&D + ST Disability

We will eventually also add a Medical PPO plan

• Participate in the development, implementation, optimization, and maintenance of the company’s Quality Management Systems

• Perform other quality or compliance related duties, as assigned by management

• Ability to develop and maintain effective working relationships at all levels of management

• Support the Equipment Program by reviewing executed qualification protocols or calibration certificates, as needed

• 3-5 years related experience in Quality Assurance, strong preference for direct QA support of manufacturing

• Knowledge and understanding of quality assurance in a manufacturing environment, laboratory controls and safety

Support in the interface with outside regulators governing safety, supporting program management, audits and process improvement

Bachelor's Degree Required - in any of the following subjects: Food Science, Environmental Health and Safety, Quality Management.

Entrepreneurial self-starter with project management qualities

Manage the facility sanitation team

Great communication and leadership skills

Strong process documentation and visualization skills, with attention to detail

·2+ years of Quality Control experience in a manufacturing environment (preferred)

· Knowledge of Sanitation GMP, HACCP, SSOP

· Demonstrates experience in the food processing environment, encouraging food safety culture with coworkers.

· Experience working under Health Department and FDA guidelines.

· Team building/team leadership skills.

· Computer skills, including Office, Excel, and PowerPoint.

Perform any related work as required, based upon experience and training, such as:

Equipment calibration and qualification form maintenance and tracking

Minimum of 0-2 years of experience in a GMP/ISO setting

Excellent interpersonal, verbal and written communication skills are required

Attention to detail, organizational skills, ability to multitask and follow tasks through to completion

Revision and creation of documents, including SOP’s and forms

B.S. Degree or equivalent experience required; Microbiology/Biology/Chemistry/Engineering related degree preferred

Strong root cause analysis and technical writing skills required

Minimum 2+ years of experience in a Quality related role – preferably in the pharmaceutical or a healthcare related industry

Experience working in an FDA or USDA highly preferred

Excellent communication, organization, and leadership skills

Ensure regular presence and provide guidance in operational areas to monitor and ensure robust compliance and quality systems

Bachelors’ degree in a scientific discipline or the equivalent combination of education and experience.

Excellent writing and communication skills and experience with use of computers and software.

Knowledge and experience with MasterControl™ or similar software would be a plus.

Generate, publish, and manage quality systems metrics to drive continuous improvement.

Supports the commissioning and qualification of new equipment, instruments, including computer systems.

Maintains and enhances validation programs for existing equipment, utility commissioning and qualification, and computer systems.

Applied knowledge of GMP, HACCP, ISO 22716, Allergen Management, Food Safety, FSSC 22000, FDA 21 CFR 210, etc

An affinity for change management and digital solutions

Responsible for performing validation/verification swabbing activities in response to equipment enhancements, facilities improvements, and annual requirements.

What We Can Offer You

Top Notch Employee Health & Well Being Benefits

You’re a dot connector: You will view the project landscape through the eyes of the consumer as well as the business.

Education: Bachelor’s degree required. Engineering or technical degree preferred. ASCP certification preferred.

Health Spending Accounts & Flexible Spending Accounts

Disability and Insurance: Short + Long Term

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