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Full-timeDescriptionThe QA Technician compliance with cGMP and SOP’s and systems. This position is responsible for daily floor monitoring., water sampling for testing, swab collection. In-process testing, line clearance. Monitor manufacturing personnel follow and adhere to SOP pertaining to Manufacturing floor activities.
Job Description/Responsibilities
- Perform line clearance, material verifications
- Collect purified water sample for testing, Trending the results
- Co-ordinate Environmental monitoring in GMP area.
- Log book and Batch record review
- Check the equipment cleanliness and Equipment Swab collection, Equipment release to the operations.
- In process QA testing.
- Archival of SOP’s, Batch documentation.
- Review the In-process SOP’s and identify the gaps
- Initiation of Change control/Incidents
- Maintain the employee training records
- Perform Any other activity as assigned by the Supervisor.
Minimum Requirements
- A background in cGMP compliance within the pharmaceutical manufacturing industry is required.
- Experience in maintaining cGMP documentation.
- Ability to manage multiple priorities and re-prioritize tasks, as required.
- Flexible and able to adapt to company growth and evolving responsibilities
- Strong attention to detail and excellent organization
Minimum Education/Experience
- High School diploma, or Associate degree.
- At least 1 to 2 years’ experience in pharmaceutical/food industry.
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Requirements
Required Qualifications:
- Quality assurance within Pharmaceutical Industry: 2 years highly preferred
- Manufacturing: 2 years (Preferred)
- Document management: 2 years (Preferred)
Knowledge & Skills
- cGMP compliance within the pharmaceutical manufacturing industry.
- Writing and maintaining cGMP documentation.
- Analyze data/information and resolve complex issues.
- Verbal and written communication skills.
- Work and communicate with cross-functional teams.
- Multiple priorities and re-prioritize tasks.
Experience & Education
- At least 2 -3 years of experience in a quality assurance role in a cGMP-regulated environment.
- A college Degree preferably in sciences (i.e., Biology, Chemistry etc.), or related discipline
