Quality Operations Primary Packaging Tier I (Shift 1 6:00 am to 6:30 pm)

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.
• 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.
• Aid in the 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.
• Adhere to cGMPs 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

• 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.