Supervisor, Quality Assurance Operations (Union, MO)
Pharma Tech Industries is a leading contract manufacturer to the world's most trusted health and wellness brands. Pharma Tech Industries is seeking to hire a Supply Chain Planner/Buyer for our manufacturing facility located in Union, MO.
Provide direction and oversight for Quality according to all GMP and SOP regulations, under the direction of the Quality Director. Roles are flexible according to requirement and focus in Quality Operations and Quality Systems.
Roles and Responsibilities:
- Provide primary oversight for the following Quality Systems:
- Quality Review and Release
- Incoming Materials Quality Assurance
- Perform analysis of associated critical Quality Metrics and Key Performance Indicators. Initiate corrective actions when necessary and performing follow-up activities.
- Seek opportunities to apply process improvements throughout Quality Operations.
- Provide support for the following elements of Quality:
- Deviations and non-conformances.
- Responsible for supporting investigations and identifying corrective actions with all operating units, QA, Site Services, and suppliers to determine root causes and corrective actions to resolve complex, compliance related issues (product failures, stability failures, and compliance issues, including supplier investigations).
- Partner with colleagues in multiple departments to ensure thorough review of manufacturing and testing records, deviations and document changes.
- Change control assessment, reviews, and/or approvals.
- Auditing and Inspection support (internal and regulatory).
- Work collaboratively with multiple departments to ensure the highest performance for the site for on-time release, quality, and customer service.
- Provide leadership and guidance, and manage the daily activities of the QA Operations team.
- Develop members of the Quality team to increase expertise in additional Quality skills.
- Provide opportunities for training and continuous education for members of the quality team.
- Identify new or emerging regulations and/or cGMP trends and transfer this information within the Quality unit and the Union site.
- Communicate effectively with all departments and employees.
- Ensure all direct reports remain current on their required training.
- Meet monthly with direct report for one-on-one communication. Complete mid-year and yearly review of each direct report.
- Key quality interface on electronic systems development and administration.
- Work with Quality Director and Quality Systems Supervisor on the following tasks:
- Coordinate activities and support interactions during regulatory agency inspections and customer audits.
- Resolve any Field Action activities (e.g. FARs, Recalls) to ensure compliance to FDA and corporate requirements.
- Provide additional support for Quality management team as required.
- Maintain current knowledge of local and international regulatory requirements and trends.
- Understand drug and food GMPs, company policies, and any associated safety practices
- Must have working knowledge of personal computers and software, including Microsoft Word and Excel.
- Must have working knowledge of pertinent company SOPs, specifications, and batch records.
- Specialized knowledge and understanding of manufacturing/ laboratory processes and material characteristics desired.
- Degree in science and/or Quality CQM preferred. In lieu of degree, eight or more years of direct experience in the pharmaceutical industry with direct experience with Quality Systems required.
- Demonstrated leadership experience required.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the job.
- Work involves walking, talking, hearing, math skills, using hands to handle, feel or operate objects, tools, or controls and reach with hands and arms. Vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus..
The above information on this description has been designed to indicate the general functions and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of any employee assigned to this job. There will be other tasks and assignments as required to ensure maximum flexibility.