Quality Assurance Inspector Or Lead

3.0 Responsibilities
3.1 In process inspection of bottles, as prescribed by First Article and In-Process Inspection procedures and assigned by the Lead Inspector. Follow all work instruction related to in process inspection.
3.2 Conduct daily dimension as required by department procedures, or Lead Inspector.
3.3 Clearly document Inspection results on Inspection sheets maintaining GMP requirements.
3.4 Conduct SPC, Vision System and Leak Detection system validation as required by department procedures.
3.5 Inspect line clearance as assigned by Lead Inspector
3.6 Release all product manufactured in the assigned shift using DC Link as per department procedures
3.7 Release reworked product using DC Link per department procedures
3.8 Identify and control non-conforming material as per company procedures, conduct back tracking for non-confirming product to assure all suspected ware has been isolated.
3.9 Document inspection results in QA log book
3.10 Communicate non-conforming product information to shift supervisor, lead inspector and group leads
3.11 Facilitate dock audits and Tailgate sampling as defined by the department procedure
3.12 Issues Quality Alerts if necessary
3.13 Responsible for maintaining a safe and clean environment.
3.14 Maintains files and related duties as assigned.
3.15 Observe and assure GMP compliance during in-process inspection.
3.16 Other duties as assigned by QA Manager
4.0 Qualifications:
4.1 Skills
4.1.1 Basic Math skills (add, subtract, divide, multiply and work with numbers up to 4 decimal places); numerical sequence of box labels.
4.1.2 Working knowledge of Microsoft Word, Excel and Access database, Lotus Notes
4.1.3 Must be able to speak, write and read effectively in order to understand packing labels, safety posters, and other forms of written communication.
4.1.4 Good vision and manual dexterity.
4.1.5 Must be able to follow both verbal and written instructions.
4.1.6 Good interpersonal skills.
4.1.7 Ability to do accurate and concise reports.
4.1.8 Attention to detail
4.2 Physical Requirements/Work Environment
4.2.1 Must be able to work eight (8) hours per day with two 15-minute breaks, and one 30-minute lunch. Must be able to work overtime on short notice.
4.2.2 Obsolete – climate control
4.2.3 Noise level is usually 90dB.
4.2.4 Some fumes on the Production floor are from plastic, cleaning solvents and oils when headed.
4.2.5 Must wear a protective foot covering, such as, rubber soled, steel-toed safety shoes. Must also wear earplugs, hairnets, bump caps and beard guards when on the production floor. No jewelry except a wedding band without stones.
4.2.6 Will lift cartons frequently, of various weight up to 45 lbs; 1 box every 5 minutes – pulling down, lifting up, stacking and moving.
4.2.7 Both arm activity to lift boxes frequently; single arm activity occasionally to do cutting and measuring.
4.2.8 Ability to visually detect difference in color, depth perception, flaws in product, letter sharpness, and read print.
4.2.9 Required to read labels on cartons, Bill of Materials, pack patterns, and other QA related paperwork.
4.2.10 Must be able to access all ground area of production floor, to move from station to station, and get to height of work area.
4.2.11 Constant bending and twisting are required on the average of 20% of the day.
4.2.12 Required to stand most of the day with occasional sitting to do measurements and paperwork. Must be able to work nine (9) hours per day, five hours per week. Extended hours may be necessary.
4.2.13 Must be able to wear PPE, such as hairnet, beard net (if applicable), rubber sole shoes, earplugs and safety glasses. No jewelry allowed on plant floor except wedding band without stones.
4.2.14 Single arm movement for writing, reading computer operation, calculator and copy machine.
4.2.15 Good visual acuity, ability to read printed material up to 1½-hour intervals at computer screen.
4.2.16 Must have good interpersonal skills, ability to interact with all employees, outside contacts and counterparts throughout the organization.
5.0 Organizational Relationship:
5.1 Reports to the Quality Assurance Manager.