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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.
Shop Floor QA Accountabilities
- 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.
Requirements
Knowledge, Skills & Abilities:
- 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.
