6+ years of experience in a quality assurance or quality control role within a cGMP environment; or equivalent combination of experience, training and/or education preferably in OTC or Pharmaceuticals.
Supervisory experience is required.
In-depth understanding and working knowledge of FDA and pharmaceutical cGMP regulations.
Solid operating skills including timely decisions, managing and measuring work along with good overall time and project management.
Proficient in Word, Excel and PowerPoint with the ability to promptly learn and master regulatory/compliance software.
Experience in electronic enterprise quality management and documentation systems are a plus.
Demonstrate strong technical ability and skills in assigned work area to include product, process and/or testing knowledge.
Ability to understand and set priorities and work load and to establish collaborative relationship with peers.
Strong interpersonal skills to positively and professionally interact with colleagues and work in a team oriented environment.
The ability to prepare and present reports to management pertaining to non-conformances.
Ability to multi task and handle a heavy volume of work.
Ability to work independently and under pressure.
Strong verbal and written communication skills.
Ability to work with a high degree of accuracy and detail.
The Manager, Quality Assurance is responsible for supporting the process of incoming material inspections, overseeing on-the-floor QA activities which include line releases and inspections. The QA manager plays a crucial support role in investigations, CAPAs and change controls. The QA manager will ensure that the operations are at a state of inspection readiness and that applicable SOPs are adhered to and cGMP is practiced. The main objectives are to ensure inspection ready status, manage and/or complete day to day Quality functions and to assist, train, and develop staff to identify and address issues related to FDA compliance, and be able to adjust quickly to changes as needed.
Responsible for assuring the quality of products manufactured at the facility.
Manage the evaluation and disposition of outsourced and in-house generated labels, cartons and inserts.
Manage the inspection and disposition of incoming components.
Support product batch record reviews and evaluation process as well as assist with required follow ups and investigations.
Hands on management and support of floor QA activities including but not limited to line release, batch clearance, quality hold and destruction processes.
Work closely with the Quality Control department to coordinate the disposition of raw materials and finished products in a timely manner.
Support the approval of Work Request Orders in Master Control.
Manages quality operations and compliance as well as inspection preparedness.
Interpret and implement scalable solutions which include quality policies.
Conduct investigations, and root cause analysis and identify root cause(s).
Recommends and implements corrective actions to prevent recurrence in collaboration with Quality Systems.
Initiate and implement CAPAs to address findings, issues and non-compliances in the facilities.
Practice Change Management utilizing risk based strategy.
Perform trend analysis to monitor process performance and report monthly production floor discrepancies and self-inspection to department head/manager.
Implement metrics to track the performance of operations and quality systems and report monthly quality KPIs.
Lead the Quality teams in the design of control strategies for new processes.
Assure that Quality and Manufacturing comply with cGMP, and other regulatory and industry standards.
Authors and revises SOP, protocols and work instructions as required, and performs risk assessments.
Continually evaluates quality systems supporting cGMP manufacturing operations for potential improvements.
Participate during FDA inspections and internal audits.
Manage and develop staff, and set priorities.
Perform all other related job duties as assigned and/or requested by company management.
Perform all responsibilities in accordance with company guidelines, Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, and regulations.