JobWatch

1+ months

Quality Assurance Associate

Kelly Services
Northridge, CA 91325
+ Title: Quality Assurance Technician

+ Location: Northridge, CA

+ Shift: Day Shift 8-hours

+ Duration of job: 4 months, Possible extended.

+ Pay: Competitive


*Must be COVID Vaccinated



Kelly Science & Clinical is excited to bring you to a great job in Northridge, CA.


Job Description:



**SUMMARY**

This position will provide support to ensure the organization maintains compliance with Quality Systems, current Good Manufacturing Practices (cGMPs), current Good Tissue Practice (cGTPs), and in adherence with all applicable Federal, State, local, international, and industry regulations and standards. This individual will actively perform a variety of activities needed to establish and maintain compliance; including but not limited to donor deferral management, nonconformance management, quality assurance and internal and external audits.


**Essential Responsibilities**

Performs job functions in compliance with internal Standard Operating Procedures, Current Good Manufacturing and Tissues Practices, all Federal and State regulations and accrediting agency standards.

Maintains training competency on applicable Quality Assurance, Quality Systems, and Regulatory policies and procedures.

Maintains all forms, logs and other applicable records and spreadsheets.

Participates in defining and revising policies and procedures related to the position.

Assists in the preparation of records prior to and during external assessments.

Maintains confidentiality of proprietary materials and information.

Assists other QA staff with regulatory and quality functions as deemed necessary.


**Donor Deferral Activities**

Maintain working knowledge of donor suitability criteria and infectious disease testing.

Reviews donor deferral information on donation records.

Maintains and updates donor deferral documentation on donation records, donor charts and all other applicable records.

Input donor deferral data into appropriate Blood Establishment Computer System including but not limited to onsite deferral, reactive test results and deferrals resulted from post donation information.

Filing and retrieving appropriate deferred donor records and/or documentation.

Counsel donor and provide information to donor regarding deferral.

Work closely with HemaCare Medical Directors to create and draft donor deferral letters and consignee notification letters.

Initiates holds on products that do not satisfy criteria. Perform necessary activities for product quarantine/retrieval/recall, consignee notifications and Federal, State and County notifications.


**Quality Assurance Activities**

Assess and triage QSR Reports and notify management and departments for any issues impacting SQuIPP of products.

Assign QSR numbers for applicable reports including but not limited to deviations, MRBs, Exceptions, Post Donation Information and adverse reactions.

Assess for deviation error codes and determine investigation categories.

Maintain the QSR log and track reports from discovery to closure.

Assist with investigations and corrective and preventive actions (CAPA).

Assist with conducting internal audits and assist during external audits.

Assign tracking numbers for internal audits and maintain all applicable documentation and records as it relates to the audit.

Maintain all applicable documentation and records as it relates to the external audit process.

Assist in compiling and disseminating of quality systems statistical data as directed and as assigned by management in preparation for Quality Assurance Management Meetings.

Assist with special projects as assigned.


Supervisory Responsibilities This Position has no direct supervisory responsibility.


**Qualifications**

To successfully perform this job the individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Meets department quality standards.

Good time management skills; ability to complete assignments within established timelines.

Ability to work with minimal supervision, set priorities, and perform multiple tasks simultaneously.

Knows and follows safety rules relative to area(s) or responsibility.

Flexibility is required to meet sudden and unpredictable needs of the department and/or the company

Ability to apply professional standards to work situations.

Discretion in handling confidential and sensitive matters


**Education, Experience and Licensure**

B.S., B.A. or Associate Degree preferred, but not required if work history is equivalent

Minimum three (3) years of related experience or equivalent combination of education and experience in a regulated environment.


**Technical Skills**

Proficient use of Microsoft Office applications including Word, Excel, Outlook and PowerPoint.

Ability to quickly learn new software programs as needed.


**Language Skills**

Must have good command of the English language and be able to communicate clearly and concisely in both written and verbal format.


**Mathematical Skills**

Compute basic mathematical equations such as addition, subtraction, division, multiplication and percentages.


Reasoning Ability The Quality Systems Specialist must be able to analyze and interpret data relating to various projects and resolve issues and problems that arise.

Must be able to resolve issues of a general and routine nature and exercise appropriate judgment to escalate issues to management.

Must be able to effectively prioritize routine and non-routine work assignments to ensure goals and timelines are met.


**Physical Demands and Work Environment** The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.

Work is conducted in the Shipping, Laboratory, Donor Center, or standard office environment. Temperatures are regulated by facilities management and are not within the direct control of the individual or HemaCare. Most work is conducted in open areas with associated distractions such as noise from telephones, keyboards, machines, door bells and talking.

Work performed in the Shipping, Laboratory and Donor Center is done primarily while standing (6 to 8 hours a day). Work performed in the office environment is performed primarily while sitting (6 to 8 hours a day). All work environments utilize keyboards, gaze at a monitor(s), utilize hands to grasp, reach and hold. The employee must frequently lift and/or move up to 10 pounds over their shoulder and occasionally lift or move up to 50 pounds. Staff who works in the Shipping / Logistics or Warehouse departments may be required to lift or move more than 50 pounds while using proper safety equipment.

Exposure to standard chemicals used in an office environment is expected. Additional exposure to Shipping, Laboratory and Donor Room staff include exposure to water, chemicals, blood borne pathogens, waste, infectious material, dry ice, and liquid nitrogen. Refer to the Safety Data Sheets for a complete list.

Staff must wear Personal Protective Equipment (PPE) when performing tasks that may expose to blood borne pathogens, waste, infections material, dry ice and liquid nitrogen or as required per policy.

Employee must use proper safety equipment, as directed


Please Quick Apply:


Send information to Kelly Recruiter: Matthew Rose


Email: Matthew.rose@kelly scientific.com


1. Current Resume

2. 3 Reasons why you are a great fit for this position

3. If you are legally able to work in the USA. Yes/No

4. Bet times for a Quick call? Mornings, Afternoons?


Looking forward to the conversations,


Thank You,


Matthew Rose


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-08-26 Expires: 2022-10-27

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Quality Assurance Associate

Kelly Services
Northridge, CA 91325

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