About the job
Quality Assurance Technicians are the quality representatives that provide support for the site Quality Management System. In addition, this position will aid with the site electronic/digital documentation system, Master Control.
Key Responsibilities
- Reviewing, filing, and maintenance of Incoming Inspection records.
- Ensuring Raw Materials have been sent out for appropriate testing.
- Review of COA/COC.
- Review, filing, and maintaining autoclave printouts.
- Reviews and interprets FDA guidance along with 21CFR210 and 211.
- Reviews equipment calibration records and maintains/updates the equipment log.
- Reviews SmartVue data to ensure temperature, pressure, and humidity are in specification.
- Reviews and maintains: NCMR log, Deviation log, Customer Complaint log, and CAPA log.
- Creates Excel workbooks to track and identify trends.
- Trains employees on cGMP, cGDP, and other topics as outlined by the Quality Manager.
- Creates, maintains, and updates Training Course Plans for all employees.
- Responsible for the Change Management System.
- Identifies key improvement areas and outlines a plan to the Quality Manager. Performs Final Check of orders at QA3.
- Performs Visual Inspection of injectable products.
- Responsible for ensuring documents are audit ready.
- Responsible for gathering data for Annual Product Reviews.
- Prepares periodic and special reports concerning Quality Assurance activities, problems, and other.
- Audits, reviews, creates, and updates Standard Operating Procedures.
- Creates Quality Assurance documents.
- Responsible for Customer Complaint Handling (communication with customer, logging, follow up, etc.).
- Assists in documentation management and control system duties through Master Control, includes maintaining both electronic and hard copies (Master Control backup). Performs document process reviews as assigned by management.
Basic Qualifications
- Business and science courses from an accredited college or university and/or at least two years of related experience and/or training.
- ASQC membership and certifications and/or active/current Pharmacy Technician License preferred. Registration(s) required by state in which pharmacy is located.
- High attention to detail is required.
- Computer literacy, including but not limited to, Windows, Office 365 Suites, and Microsoft Teams.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to apply mathematical operations to such tasks as sampling theory and factor analysis.
Working Conditions
- This position requires standing and sitting for extended periods of time including majority of shifts. Walking, kneeling and bending frequently.
- Employees will be required to lift and carry up to 30 pounds.
- Employees will be required to read small print.
- Employees will be required to don Gown and PPE.
- Employees will be required to handle hazardous drugs as outlines in NIOSH, including spill cleanup with proper PPE when required.
- While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of radiation. The noise level in the work environment is usually moderate.
What's on offer?
At AnazaoHealth, you'll find plenty of opportunities to grow and make an impact. We offer competitive pay, a comprehensive benefits package (including 401k and Volunteer Paid Time Off), and a supportive workplace where your ideas and talents can shine.
We're proud to be an Equal Opportunity Employer and maintain a drug-free workplace. Diversity makes us stronger, and we're committed to building an inclusive environment where everyone feels welcome.
Ready for the challenge?
Take the next step and join us in shaping the future of personalized medicine. Apply online today and don't forget to include your salary requirements.
No phone calls, please.
We do not accept agency referrals for this position.