work environment This job operates in a professional office environment and business casual attire with closed toe shoes and socks are required.  This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.  This role requires Good Hygiene and hair / facial hair must be kept well-trimmed to prevent incidental contamination during testing.  Working with Biohazardous materials is also prominent.   physical demands The physical demands described here are representative of those that mus...

• Must be a self-starter and self-motivated and able to work perform primary tasks with minimal supervision. • Write, review, and approve batch records, validation documentation and validation studies and reports on solid dosage forms including tablets and capsules and liquid dosage forms including solutions and suspensions in accordance with FDA regulations/guidelines. • Lead manufacturing process validations, process capability studies and process improvements, provide leadership to QE personnel and technicians. • Review, analyze and assess...

RESPONSIBILITIES: • Routinely clean, maintain, and organize lab glassware and instruments • Maintain, organize, track and order  the consumables/chemicals in the lab • Dump hazardous waste and expired solution as needed • Perform other routine tasks that occur in the lab under supervision • May perform non-routine tasks under the direction of supervision   DEMONSTRATED KNOWLEDGE, SKILLS and CHARACTERISTICS: • Accountable and fair: maintain a fair amount of accountability to themselves and the lab. • Developing knowledge on handl...