QO Primary Packaging Senior

Description

Job Purpose:

•  Provide assistance to the QA Supervisor in training, guiding, coordinating, and evaluating the workforce, providing problem solving and compliance support.
• Performs Weight Check and Quality Attributes Inspection of the product through the filling and/or packaging process in compliance with company policies / procedures, FDA and cGMP regulations.
• Ensures the accuracy and completeness of batch records.
• Assists with additional work duties or responsibilities as evident or required.
• Performs other duties as assigned or apparent.

______________________________________________________________________________

Essential Duties and Responsibilities:

NOTE: The primary accountabilities and knowledge, skills and abilities are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager. Failure to execute these duties and responsibilities may result in disciplinary action up to and including termination.

• Successfully complete Quality Operations Training as outlined per procedure.
• Perform all job duties in accordance with applicable procedures.
• Coordinate and conduct training and retraining of QA On-Line personnel with Trainer to ensure compliance of procedures.
• Assists with GMP training to QA On-Line personnel.
• Monitors and perform start up, in-process and finished product inspections including weighing. 
• Maintain quality assurance documentation.
• Promotes teamwork both within the QA Team and other departments.
• Monitor all production areas and personnel for adherence to all cGMP, SOP’s and safety regulations. 
• Keep line and work station clean and orderly.
• Verify incoming packaging materials, raw materials, in process and finished products. 
• Ensure that there is no product line contamination.
• Perform line clearance including equipment, components and label verification.
• 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
• Release finished product for packaging.
• Investigates out of range percentages.
• Review QA procedures and component specifications for compliance and clarity.
• Ensures documentation systems reflect accurately both processing steps and accountability.
• Provides direction and assistance in documentation, team forming, and solution of problem solving and process improvements.
• Ensures compliance with current procedures 
• Notifies QA Supervisor / QA Manager or designee immediately of deviations that involve mislabeling or product safety & any non-Compliance or non-conformance issues.

______________________________________________________________________________

Supplemental Functions:

• 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.

______________________________________________________________________________

Knowledge &Skills:

• 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.

Abilities:

• The ability to create and contribute to an 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. 
• The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.
• The ability to manage a multitude of resources and to be accurate and current with data and information.

Education/Experience:

• Associate of Science Degree preferred; High School Diploma or GED required
• Minimum of 1 year with pharmaceutical experience preferred 

______________________________________________________________________________

Working Conditions/Physical Requirements:

Position requires reaching, bending, lifting (up to 25 lbs), reaching, vision, standing (40%), sitting (20%), walking (40%), typing, and hearing.

Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.