Weekend QA Administrative Assistant

EMPLOYEE JOB DESCRIPTION

PROCESS OWNER: Quality Department

JOB TITLE: Quality Admin

JOB PURPOSE:

The Quality Assistant serves as the department’s primary administrative support. As part of the company’s quality assurance cGMP compliance strategy, the Quality Assistant manages official records from pre-production issuance to archival retention. To this end, the position encompasses wide-ranging and shifting roles, as needed, and requires a willingness to adopt new and evolving projects. This is for a weekend position.

JOB DESCRIPTION:

• Participate in updating Quality Management System (QMS) including manuals, procedures, work instructions, logs, and forms to maintain high standards of quality, reliability and safety, and making sure that only relevant versions of documents are available at points of use.

• Manage the document life-cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification.

Direct/conduct internal quality audits and assists in maintaining overall audit program. Assists during external audits by customers, consultants, certifying agencies or regulatory agencies. Assists in managing electronic and paper trail required for all quality control and assurance functions in an easy and retrievable manner for easy trackability and traceability. Perform final quality assurance release of finished products after thorough review of QC documents. Meet all requests in a timely manner by coordinating with vendors and reviewing all documents before submitting to customers, vendors, consultants, and regulatory bodies by being an interface between internal and external customers.

Maintain original training records for all associates to support cGMP compliance. Coordinate with other departments as necessary in establishing standards relative to ensure product quality. Review, evaluate and obtain disposition for in-process rejections, CAPA, rework, deviation, change request, material destruction, material reviews, customer complaints etc. Assures compliance with internal Quality initiatives, cGMP and standards established by regulatory bodies. Coordinate between concerned departments for any Quality related issues as well as to make sure all requirements for production are met within required timeline. Assists with assembling documentation packages for regulatory agencies for international certifications as well as for any customer requests. Environmental monitoring execution. Resolve quality-related issues in a timely manner by taking immediate action towards product improvement. Provide technical support to Operations and Management teams as and when needed. Communicate issues, new information, changes to relevant departments.

Support Audit and cGMP from regulatory standpoint to help Nutracap Labs meet FDA standards for compliance. Maintain safe and healthy work environment by following Standard Operating procedures (SOPs),

Work Instructions, and complying with legal regulations. Update job knowledge by participating in educational opportunities and reading technical publications. Accomplish quality and organization mission by completing related results as needed. Maintain organized and efficient workflow and demonstrate high degree of accuracy. Prioritize and complete on-going tasks assigned by Quality Manager.

SKILLS: Written and verbal communication skills including ability to speak and communicate in person, email, and telephone effectively and efficiently. Ability to work with mathematical concepts such as probability and statistical inference, fractions, percentages, ratios, and proportions to practical situations, solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Basic computer skills and working knowledge with spreadsheets and word processing software. Attention to detail with strong organizational skills. Documentation skills. Quick, self-starter and able to work independently. Good record keeping. Hand/eye coordination. Reporting skills. Blueprint reading. Ability to work under pressure and a team player. Ability to read and interpret documents common to the technical and operational functions such as product specifications, departmental instructions, procedure manuals, certificates of analysis, production records, and governmental regulations.

Ability to write routine reports and business correspondence. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

QUALIFICATIONS: Bachelor's degree in Food science, Nutrition science, Pharmacy and/or any related Biological science from a four-year college or university is preferred. A minimum of two-year experience in Quality Assurance or Quality Control, preferably in the dietary supplement, food, or pharmaceutical industries with at least one year experience in documentation management.

• Basic knowledge about Good Manufacturing Practices (GMP, cGMP), Standard Operating Procedures(SOP) and regulatory requirements.

• Demonstrated proficiency in writing and composing.

• Basic computer job skills including logging on to systems, ability to communicate by email, recording and updating database, create power point presentations, download forms, and preserve/backup important data. Intermediate to advanced skill in Microsoft Word and Excel required.

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

• Excellent attendance and reliability.

JOB TYPE: Full-time, 40hours/week. Position is M- F. Occasional weekends depending on requirement.

Job Type: Full-time

Pay: $18.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 10 hour shift
• 8 hour shift
• Weekend availability

Supplemental Pay:

• Bonus pay

Ability to commute/relocate:

• Norcross, GA 30093: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• Microsoft Excel: 1 year (Required)
• Quality assurance: 1 year (Required)

Work Location: One location