Supervise and coordinate activities of QA Inspectors who perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards.
Responsibilities
Schedule duties and work assignments of all QA Inspectors.
Supervise QA Inspectors to ensure that quality issues are resolved and documented in a timely and efficient manner.
Ability to learn and perform activities of workers supervised.
Monitor manufacturing and QA areas for compliance with internal SOPs and FDA GMP regulations.
Ensure that all work activity is documented accurately in appropriate batch records, forms, and logs and is in compliance with requirements.
Ensure that samples are processed and distributed to different departments in a timely manner.
Review records for GMP compliance, accuracy and thoroughness.
Investigate failures and deviations in manufacturing operations and initiate corrective action. Issue SICODs and perform/document investigations pertaining to SICODs when required.
Inform management of problems, failures and deviations from established internal and regulatory requirements.
Train departmental personnel. Maintain QA Inspector Training curriculum and all associated training documentation. Direct all training activities for the department
Ability to effectively mentor staff for continuous improvement
Assist management in the development, execution, and monitoring progress towards departmental goals/objectives
Prepare and conduct staff performance appraisals, development plans, and disciplinary activities as warranted.
Draft and revise departmental SOPs, forms and documents. Update procedures to reflect new or changed products, processes, equipment, policies, FDA regulations, customer demands, etc. and to ensure they are current.
Assist in Validation Projects.
Provide status/monthly reports to management.
Analyze and resolve work problems. Interface with customers to address quality and or Batch Record issues.
Participate in various QA activities and meetings in support of departmental functions.
Assist production in providing QA Inspector support (i.e., scheduling QAI area coverage).
Initiative required to generate ideas for improved process efficiency/continuous improvements within general procedural guidelines.
Responsible for assisting management in monitoring and periodic reporting of monthly/quarterly metrics and quality indicators, including but not limited to QA Hold task, QAI related activities, sampling failures, deviations, etc.
Responsible for assisting management in driving and providing support in the troubleshooting of Quality Systems and implementation of systemic/procedural enhancements aimed at making such systems more robust.
Qualifications
Competencies:
Education / Experience:
Minimum Bachelor degree, preferably in Sciences or related technical fields. A minimum of five years work experience in a pharmaceutical GMP environment, preferably in QA or related functions directly overseeing manufacturing operations. A minimum of three (3) years supervisory experience ASQ Certifications preferred. Demonstrated knowledge of cGMPs, FDA/DEA regulations and sampling methodologies. PC literate with basic knowledge of office application software. Good communication (written and verbal) skills.
Judgment / Decision Making:
Under general direction with periodic reviews of assignments and performance measures. Duties performed within a framework of departmental or functional protocol requiring a moderate degree of original and critical thinking and minimal supervision. Makes routine and informed decisions. Demonstrate Leadership principles.
Work Environment:
Majority of time spent at manufacturing plants with exposure to machines with moving parts airborne products, chemicals, muscular strain and noise. Carelessness could result in minor injury.
Physical Demands:
Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds. Visual acuity and manual dexterity required to proofread documents and operate computer. May handle or work with laminates and units containing a Class II Controlled Substance.
