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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.
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