Description

Position Summary

✓Performs Weight Check and Quality Attributes Inspection of the product through the filling and packaging process in compliance with company policies/procedures, FDA and cGMP regulations.
✓Ensures the accuracy and completeness of batch records.
✓Performs other duties as assigned or apparent.

Primary Accountabilities

✓Successfully complete required Quality Assurance Training as outlined per procedure.
✓Successfully complete DEA certification.
✓Review production batch records for accuracy and completeness.
✓Monitor and perform start up, in-process and finished product inspections including weight checks and attribute inspections during production.
✓Maintain quality assurance documentation.
✓Promote teamwork both within the QA area and other departments.
✓Keep line and work station clean and orderly.
✓Inspect and release machines and processing rooms for production.
✓Support validation and manufacturing studies including special sampling and testing.
✓Organize workload during lot and batch changeovers for efficient execution.
✓Review and approve production batch records for release into production.
✓Investigate out of range percentages.

✓Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.
✓Assist with development of solutions for chronic problems within quality assurance
✓Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.
✓Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
✓Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
✓Assist in other activities (as needed) for Quality Assurance management.

✓High School Diploma or GED.
✓Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of cGMP preferred.
✓Detail oriented.
✓Good computer skills in MS Outlook, MS Word, MS Excel, internet, email and basic typing skills.
✓Good visual acuity and observation skills
✓Good written, oral and comprehensive communication skills.
✓Able to handle diversity of projects.
✓Specific expertise, skills and knowledge within quality assurance gained through education and experience.
✓A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
✓The ability and willingness to change direction and focus to meet shifting organizational and business demands.
✓The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
✓The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
✓Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs.), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing, and hearing.
✓Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.