Quality Assurance Specialist II Job at Planet Group, Newark, CA

Y1FrL2t5WlFWTHlOUnh2SWUyNEFCS2x3UWc9PQ==
  • Planet Group
  • Newark, CA

Job Description

JOB SUMMARY:
The Quality Assurance Specialist II is an intermediate level position with hands-on QA and QC experience. Under moderate supervision, the individual will be working primarily on quality systems, the reserve sample program and incoming attribute inspections.  The Quality Assurance Specialist II is an intermediate level position with hands-on QA and QC experience. Under moderate supervision, the individual will be working primarily on quality systems within the Product Quality Assurance group to support QC and AD related processes specifically method validation projects.

ESSENTIAL DUTIES: **Perform QA review for AD method validations projects.
**Perform QA review for QC related quality system records including deviation, CAPAs, Change Controls, and OOTs. Assist in QA review of QC related equipment and process validations.  • Perform a wide variety of quality assurance activities to ensure compliance with internal procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development.
• Review, approve, and track closure of the change controls, deviations, quality investigations and CAPAs.
• May support quality operations, as needed (e.g., review executed records such as batch records/ quality control data or equipment qualifications; perform line clearance and product inspection; review other records under supervision such as change control requests, deviations, lab investigations, environmental monitoring excursions, proposed CAPAs).
• Support continuous improvement of quality systems. Author new, revise existing department procedures and/or forms.
• Assist in internal compliance audits as needed.
• Provide inspection readiness support and assist during inspections by regulatory authorities or other third parties.
• Other duties as assigned.

WORK ENVIRONMENT and PHSYICAL DEMANDS:
This section of the job description is required by the American with Disability Act, (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” • Prolonged periods of sitting at a desk and working on a computer. • Must be able to lift up to 10 pounds at times.
Skills:    
**Experience within QA and QC/AD departments.
**Candidates with only QC/AD experience will be considered. • Minimum 4 year’s experience performing quality functions in pharmaceutical and/or biotech related fields.
• Working knowledge of quality systems cGMP standards applicable to biologics DS and DP.
• Works under moderate supervision.
• Ability to independently analyze and reconcile simple issues.
• Ability to organize and manage multiple tasks in a fast-paced environment, with minimal instruction on routine work and moderate instructions on new assignments.
• Good verbal and written communication and interpersonal skills.
PREFERRED ADDITIONAL SKILLS (I.E., COMPUTER): • Proficient with commonly used word processing, database systems and other software. Experience with Veeva a plus.
Education:     • BS or equivalent in biology, chemistry or related science or equivalent experience.

Pay Rate Range: $30-43/hr depending on experience 

Job Tags

Contract work,

Similar Jobs

Mai Placement

Junior Project Coordinator Job at Mai Placement

 ...Junior Project Coordinator (Entry-Level) Wayne, NJ Salary: $45,000 - $60,000 (based on experience) Company Overview: We are a fast-growing construction trade company located in Wayne, NJ. We are seeking an energetic, detail-oriented candidate to join our team... 

J Danielle & Co.

Weekend CNA for patient with Dementia in RSF area of SD Job at J Danielle & Co.

 ...RSF are specifically looking for someone who is interested in working weekend hoursSaturdays and Sundays from 1:00 PM to 7:00 PM. Ideally, the candidate will be a Certified Nursing Assistant (CNA) or possess comparable experience, particularly with dementia care.... 

Get It - Healthcare

Clinical Psychologist - Remote Job at Get It - Healthcare

We are seeking a dedicated and skilled Clinical Psychologist to join our team of medical professionals and support our mission of providing exceptional healthcare to veterans. In this role, you will conduct one-time, non-treatment disability exams for veterans in Fort Wayne... 

Domino's Franchise

MILEAGE PAID NIGHTLY $20 / hour as a Pizza Delivery Driver Full-time Job at Domino's Franchise

 ...you be more efficient which allows you to take more deliveries per hour than other delivery places, increasing your tips! Tips and mileage...  ...your shift between 4pm-6pm and leave at close, around 1am. $20/ hour is wage, mileage, and tips combined. You may not make that... 

ReadMe

Full Stack Engineer Job at ReadMe

 ...companies build beautiful, personalized, and interactive developer hubs. If youve ever visited the developer docs for Apple, Notion, or Nvidia, youve used ReadMe! We love what we do because its so much more than just documentation. Were providing tools for teams to build...