Description

The 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