Technician I - Quality Engineering

Validation

PRIMARY TASKS:
?  Must be a self-starter and self-motivated and able to work with some supervision and mentoring.
? Write, edit, format, and review manufacturing and packaging batch records.
? Be able to review data for validation reports and validation protocols.
? Peform basic math calculations (addition, subtraction, multiplication, division, percent).
? Assist with installation and operation qualification (IQOQ) and PQ for manufacturing and packaging equipment.
? Open Change Controls, CAPAs, Deviations and Investigation documentation as needed, complete within prescribed deadlines.
? Support Quality Engineers in sampling, reviewing documentation, reviewing data, preparing validation binders and organizing validation paperwork.
? Perform packaging line studies as needed for new bottles and caps.
? Prepare and weigh sample vials, generate labels, and input weights in Excel for blend uniformity and cleaning validation. 
? Assist with or perform blend uniformity sampling if required.
? Assist with or peform cleaning validation swabbing as needed.
? Clean the validation equipment (sampling thiefs, dies, etc), calibrate balance, pH meters and other equipment as needed daily.
? Perform other duties as may be assigned by the management.

SKILLS NEEDED:
? Experience and proficient using a computer and with MS Word and/or MS Excel.
? Strong communication, organization, and time management skills are necessary.
? Ability to prioritize work per business needs in a fast-paced environment.
? High degree of accuracy and attention to detail required.
? Excellent interpersonal skills, team work oriented with a positive attitude.
? Willing and eager to learn and adapt to changing schedules or work priorities.

EDUCATION/TRAINING:
? High School Degree or GED.
? Minimum of 6 months of pharmaceuticals experience in production manufacturing, or quality.
? Familiarity working in a cGMP and GDP facility.

PHYSICAL DEMAND/WORK ENVIRONMENT
Job requires standing and sitting as needed.  Walking, primarily on a level surface, periodically throughout the day is also required.  Reaching above shoulder height, below the waist and/or lifting may be required to file documents or store materials throughout the workday.  Proper lifting techniques required.  Activities may include occasional lifting up to 50 pounds for files, computer printouts and other mostly office related items.  The performance of this position may occasionally require exposure to manufacturing areas where, under certain circumstances, personal protective equipment such as safety glasses with side shields and hearing protection and/or PAPR are mandatory.  The primary environment will be ambient room temperature, office lighting and exposure to traditional office equipment as found in a typical office environment.