Quality Assurance Specialist - Forsyth, MO
About The Position
The Quality Assurance Specialist provides direct support for Quality Systems under the guidance of the Director of Quality Assurance. The role helps maintain those systems through periodic system and equipment verifications, coordinating calibrations and equipment maintenance or installation, assisting with validations, completing auxiliary quality programs, and supporting investigations. The specialist reviews finished-goods materials and batch records and approves batch paperwork, working closely with Document Control, Quality Control, and Production to complete and document tasks on time. The position also provides quality support on the production floor, including monitoring cGMP adherence, promoting accurate and complete production documentation, and supporting investigations, verification, and implementation related to non-conformances and deviations. The specialist develops knowledge of regulatory requirements and cGMPs and gains competency in activities that facilitate product release. Duties include document control and records management, reviewing and approving certificates of analysis and batch folders, collecting samples and data for investigations and validations, reviewing validation and investigation data, and completing verification activities. The role prioritizes document review around release dates, coaches manufacturing personnel on documentation, coordinates with Production to resolve documentation observations, and manages equipment maintenance and calibration documentation. The specialist also contributes to continuous improvement, helps investigate production-floor deviations, supports development and training on procedures and forms, and performs or manages Quality System verifications. The position may have other assigned duties and is responsible for creating and maintaining policies and procedures affecting the purity, quality, and composition of products manufactured by Deerland. The role requires use of computer systems and quality/testing equipment, including a hardness tester, disintegration apparatus, friability tester, balances, and office equipment. A working knowledge of equipment used is essential. The position is based on-site in Forsyth, Missouri. The work environment is usually low to moderately noisy, with occasional exposure to loud machine noise. Occasional lifting or moving of up to 25 pounds is required. Successful completion of a background check is required.
Requirements
- Bachelor’s degree from a four-year college or university and one year of related industry experience and/or training, or an associate’s degree and five years of related industry experience.
- Valid driver’s license.
- Ability to read and interpret scientific and technical journals and legal documents.
- Ability to respond to regulatory agencies and customers when required.
- Excellent verbal and written communication skills.
- Ability to calculate proportions, percentages, and statistical data.
- Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.
- Ability to assess policies, procedures, and processes for compliance with applicable standards.
- Ability to apply corrective and preventive action principles to situations and incidents.
- Computer literacy in word processing and spreadsheet functions.
- Strong attention to detail and ability to critically examine processes and procedures.
- Ability to work amid rapidly changing priorities and varying levels of intensity.
- Working knowledge of equipment used in the role is essential.
- Successful completion of a background check.
Nice To Haves
- Knowledge of Statistical Process Control and Quality Engineering.
Responsibilities
- Perform document control activities, including reviewing and approving certificates of analysis and batch folders and maintaining required records.
- Alert the Quality department to deviations from specifications and assist with investigations by collecting data or samples.
- Coordinate with Planning, Operations, and Technology to ensure batches and raw materials are ready for release by due dates.
- Carry out validation and verification procedures to confirm systems comply with requirements.
- Collect samples for laboratory or other testing related to investigations, validations, or trending.
- Support or perform laboratory analysis on validation or verification samples as required.
- Review and compile data from validation, verification, and investigation activities.
- Perform verification activities to confirm implementation success for processes or action items.
- Complete, review, and send release records to Quality Assurance or other interested parties.
- Prioritize document review to align with product release due dates.
- Coach and mentor manufacturing supervisors and operators on documentation.
- Coordinate with Production to discuss, resolve, and eliminate documentation observations.
- Manage equipment maintenance and calibration programs and ensure related documentation is completed, including before use where applicable.
- Collaborate on continuous improvement initiatives and action plans.
- Collaborate with team members to investigate production-floor deviations during shifts.
- Work with relevant groups to resolve outstanding process-document and logbook issues, cGMP walkthrough inspection observations, and quarantine management matters.
- Assist Production, Maintenance, Quality, and Engineering with developing, writing, reviewing, and training on standard operating procedures, policies, work instructions, and forms.
- Perform or manage Quality System verifications, such as lighting and pressure-differential verifications.
- Create and maintain policies and procedures affecting the purity, quality, and composition of manufactured products.
- Perform other duties as assigned.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
