Quality Assurance Specialist II
7555 Gateway Boulevard Newark, CA 94560 US
Job Description
JOB SUMMARY:
- The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience.
- Under moderate supervision, the individual will be working primarily on quality systems, the reserve sample program, and incoming attribute inspections.
- The individual will also assist in the quality operations area, such as batch record and quality control data review, line clearances, AQL inspection, and will interact with cross-functional groups such as Quality Control, Manufacturing, and Regulatory Affairs.
ESSENTIAL DUTIES:
- 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.
- Assist in the management of the reserve sample program.
- Perform incoming quality attribute inspections.
- Review, approve, and track closure of the change controls, deviations, quality investigations, and CAPAs.
- Prepare quality system metrics.
- Review and disposition of incoming raw materials.
- 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 PHYSICAL 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.”
Physical Demands:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 10 pounds at times.
EXPERIENCE:
- Minimum 4 years of experience performing quality functions in pharmaceutical and/or biotech-related fields.
- Some working knowledge of quality systems cGMP standards applicable to clinical 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 instruction 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.
Education:
- BS or equivalent in biology, chemistry, or related science or equivalent experience.
Pay Rate Range: $25-45/hr depending on experience
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