Sr QA Inspector-3rd Shift (11:00pm-7:30am)

Overview: The Senior Inspector job function ensures compliance with Andrx operating policies and procedures and regulatory requirements for Quality and Operations. Performs services for the control, management, testing and secure storage of excipients, active pharmaceutical ingredients, intermediates, finished dosage and contract-manufactured materials. Creates Standard Operating Procedures (SOP) to provide controls, manage testing, secure storage, retrieval and retention of all materials. Maintains Quality Databases to track and monitor status of materials (e.g. JDE MRP system, Trackwise®). Provides technical quality support among facilities to ensure compliance with Andrx policies and procedures and regulatory requirements. Serves as a team member of projects to improve overall effectiveness of the inspector job and harmonizes with Operations. Performs quality-related activities that support specific objectives and/or business needs. May act as the Technical Quality Assurance/Control Inspector, when designated.Responsibilities:
Within Quality Assurance role performs releases of the room, equipment, ancillary parts, staged materials for excipient, active pharmaceutical ingredients, intermediates, finished dosage, and contract manufactured materials.
Completes all associated required documentation.
Conducts prepares and applies labels to materials/samples.
Facilitates data accuracy by use of the JDE MRP system or other electronic system.
Uses various software applications (e.g. QUMAS®, TrackWise®, JDE, etc.) for the creation, tracking and storage of materials/documents.
Shares responsibility for the accuracy of the JDE inventory system.
Controls and monitors access to secured materials.
Oversees sample delivery to the laboratory.
Ensures material review, storage, re-issuance, and changes are conducted in accordance with quality policies, procedures, and SOP’s.
Ensures appropriate retention policies are followed based on type of material.Oversees the preparation of material records.Evaluates current standard operating procedures and provides recommendations for improvement.
Assists with investigations conducted by quality and operations staff.
Conducts product labeling of materials (as required).Carries out routine in-process monitoring during encapsulation, compression operations, and packaging at intervals defined by SOP’s.
Carries out statistical sampling of materials as required by SOP’s and in addition whenever required to do so.
Monitors and records differential pressure readings of work area (usually room or equipment-hood) to confirm work area are suitable for use as required by SOP’s.
Notifies QA Management of discrepancies or deviations.
Ensures that cGMPs and safety rules are followed at all times.
Performs additional related work as assigned. Ensures that the production schedule is followed, production needs are met and the transition meeting between shifts takes place in a timely manner.
Receives training on related safety, standard operating procedures, emergency response procedures, MSDS (Material and Safety Data Sheets) and use of the forklifts as needed.Job Requirements
Qualifications:
Associate Degree with fifteen (15) hours college level science, math or computer science credits; or the equivalent e.g. minimum of three (3) to five (5) years of production or quality experience.Considered above an entry-level Quality department position, a potential candidate will have no less than two years Quality Assurance/Control related experience.
Works with limited supervision to inspect, test, and secure all materials and process in accordance with SOPs or in conjunction with guidance of Manager/Supervisor of Quality Assurance.Demonstrates good written and oral communication skills
Effectively prioritizes individual work
Demonstrates consistent high quality work including attention to detail, meeting timelines
Has intermediate-level computer skills
Has excellent analytical and problem solving skills
Has good observation skills
Demonstrates the ability to focus on attention to detail on a consistent basis
Able to effectively provide direction to team members
Applies technical knowledge in assisting in planning/conducting an investigation
Able to identify a trend and interpret data from control charts
Effectively deals with stress
Able to successfully coach and mentor team members
Maintains a valid Florida drivers license
Lifting of materials up to 35 pounds as required