QA Technician/Auditor

Position Summary:

· The QA Technician performs quality assurance duties to prevent or eliminate defects in products for sterile filling operations or in final inspection and packaging operations.

· This individual must work in a detail-oriented, compliant manner in a high-stress environment where adherence to deadlines is critical.

· The individual must display an exemplary level of integrity at all times.

· Manage a workload of varying priorities while adhering to strict deadlines.

Essential Duties & Responsibilities:

· Monitor the production process and ensure consistency of procedures.

· Perform visual inspection of finished product.

· Perform AQL testing of finished product.

· Review in process documentation.

· Audit manufacturing rooms for adherence to cGMP and SOPs Audit the maintenance of a clean and sanitary environment.

· Review daily/weekly/monthly and bi-monthly logbook entries for completeness.

· Review, approve and issue verified -clean green release stickers to operations.

· Check machine settings.

· Observe/mentor personnel on aseptic performance.

· Perform line clearances and review documentation (circular charts, autoclave tapes etc.) to allow operations to initiate production (release to fill).

· Obtain and maintain gown certification for clean room entry.

Must Haves:-

• At least 5 years of experience in QA, or a combination of QA and manufacturing, with a balanced ratio of 50:50.
• Education in Pharmaceuticals, Biotechnology, Chemistry, or Biology.
• Experience with a variety of dosage forms, including Ophthalmics, ampules, liquid, and vials.
• Hands-on experience on the shop floor (as Supervisor/production chemist) is advantageous, with a focus on line clearance, troubleshooting, and guiding manufacturing teams to ensure adherence to sterile behaviors.
• Background in BioTechnology (Downstream process) within the pharmaceuticals sector is desirable.
• Target job titles include QA Auditor, inspector, in-process QA, IP QA, and Shop floor QA.
• Familiarity with GMP environments is a must.
• Previous experience specifically in injectables within pharmaceuticals or biotechnology companies.
• Experience with liquid sterile injectables and liquid dosages such as Ophthalmic solutions.
• Do not look for candidates who has worked on Solid Oral Dosage
• Experience with Powder for injections and Ophthalmic liquid is highly valued.

Education and Experience:

· Associate's Degree or equivalent from a two-year college or technical school;

· One year related experience and/or training; or equivalent combination of education and experience.

Job Prerequisites:

· All full-time employees are required to work a 40-hour week.

· At times, additional hours during the weekdays, evenings, and/or weekends will be required to complete tasks and meet deadlines.

· All applicants must be able to meet the attendance standards.

· Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820), and other FDA regulations and guidances.

· Have general math skills: adding, subtracting, multiplication, division, and percentage calculation.

· Ability to calculate figures and amounts such as discounts, interest, commissions, and proportions.

· Able to use personal computers and standard office equipment such as fax and copy machines, calculators, and printers.

· Aptitude to learn computer programs as needed (i.e. Microsoft Office Word, Excel) in addition to other business applications.

· Strong verbal and written communication skills.

· Resourceful and well organized.

· Ability to read and interpret standard documents such as: procedure manuals, employee handbook, and job related publications.

· Ability to write routine reports and correspondence.

· Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

· Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Job Type: Full-time

Pay: $30.00 - $33.00 per hour

Schedule:

• 8 hour shift
• Overtime

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)
• Night Shift (Preferred)
• Overnight Shift (Preferred)

Work Location: On the road