Quality Systems Specialist - Atlanta, GA
Deerland Enzymes, Inc.
The Quality Systems Specialist provides direct Quality support to the continuous improvement of the QMS. The Quality Systems Specialist, with guidance from the VP of QA / RA, ensures the quality of various svstems throughout multiple departments.
The Quality System Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas are in compliance, and will train on and gain competency in activities as they relate to quality and adherence to various standards. Specific responsibilities include but are not limited to the following:
- Review new or revised Standard Operating Procedures (SOPs) and forms for compliance with applicable regulations.
- Assist other departments in the development, revision, and preparation of SOPs and forms in accordance with policies, regulations and protocols.
- Advise and assist in the establishment of calibration protocols and maintenance records in accordance with cGMP, cGLP and/or regulatory requirements.
- Assist in the review, trending, and management of equipment, calibration, and maintenance records.
- Advise and assist with development and execution of validation and qualification of methods, processes, and equipment; Review assay validations. Perform validations as required.
- Carry out OOS investigations ensuring proper identification of failure mode, root cause, and corrective/preventive action as well as clearly written summaries.
- Conduct CAPAs investigations, deviation and nonconformance reporting, and other quality system documentation.
- Assist QA Management in gathering data and trending of Quality Objectives, QMS, and other quality data.
- Generate and present reports on departmental activities and efficiencies.
- Provide guidance and train others on Quality System and Quality Assurance procedures.
- May be called upon to review data, protocols, reports, technical specifications, and spreadsheet validations.
- Assist in conducting hazard analysis and product evaluation for raw materials
- Review and approve specifications for laboratory reagents, supplies, and materials in accordance to ISO standards.
- Coordinate stability operation activities and ensure quality products and systems
- Determine stability sample requirements and oversee execution of stability protocols
- Monitor stability rooms and environmental conditions on a daily basis to confirm acceptance with established specifications
- Prepare stability data graphs to estimate expiration dates and verify product shelf life
- Evaluate stability trends and prepare reports
- Initiate action reports or deviation reports for any applicable nonconformance
- Assist with the filing and archiving of stability studies
- Provide a quality review process for data generated in the stability group
- Work closely with Director of QA/QC regarding work scheduling and assignments
- Work with internal and external auditors; may be required to act as spokesperson on behalf of company
- Work with accounting on administration of stability storage charges
- May recommend cost improvements and provide advice on routine operational procedures as related to stability testing
- May serve on project teams
- Performs other duties as assigned.
- Minimum - 4 year university degree
- Preferred - 4 year university degree in science, biotechnology, or other related field.
- Minimum - 1+ years quality experience in an FDA regulated facility.
- Preferred - Experience in Federal and State Food Safety Regulations including HACCP and GFSI
- Preferred - Experience with food safety and defense programs
Specific Skills & Abilities:
- Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment
- Strong leadership skills
- Strong knowledge of current quality systems requirements and implementation techniques.
- Superior communication and analytical skills, plus demonstrated skills to handle a variety of assignments simultaneously .
- Customer-advocate to ensure on time task completion.
- Requires excellent written and verbal communications.
- Must have the ability to assess situations and develop solutions
- Must have excellent attention to detail
- Must have the ability to adjust to changing work demands and priorities in a fast paced environment
- Experience with Microsoft Office products with an emphasis on Excel
- Strong analytical experience
- Ability to learn new technologies quickly
- Results driven, strong work ethic
- Strong organizational and time management skills
- Ability to work with mathematical concepts such as probability and statistical inference .
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Must be able to walk, bend, kneel, stoop, climb, reach and grasp for varying periods of time
- Ability to work flexible schedules including nights and weekends
- Fluent in English required, bilingual (Spanish) preferred
- Must possess a valid US driver's license