Document Control & Training Coordinator - PB

HERB PHARM LLC•Wilderville, OR
•$20 - $23•Onsite

About The Position

The Document Control and Training Coordinator supports the Quality Department through document management, data entry, training, and administration of training materials. The role also supports routine quality control activities, including finished-goods release, review and release of Certificates of Analysis, and equipment quality checks. The successful candidate is detail-oriented and works accurately and promptly, with strong prioritization, time-management, multitasking, troubleshooting, and communication skills. This position schedules and supports training, maintains training records and the online training platform, creates and maintains controlled documents, and helps ensure documentation meets safety and GMP requirements. It also provides clerical and technical documentation support, creates product Certificates of Analysis, supports mock recalls and commissioning documentation, and performs other quality control tasks as needed. The role has no supervisory responsibilities and reports to the Quality Manager. The position is full-time, non-exempt, and based onsite in an office and manufacturing environment at Pacific Botanicals in Grants Pass, Oregon. Pay is $19.50–$22.50 per hour, depending on qualifications, skills, and relevant experience. Some duties take place in cGMP areas where required protective clothing and restrictions on personal products and jewelry apply.

Requirements

  • Associate degree in a related field, or an equivalent combination of education and related experience.
  • At least 2 years of related experience and/or training in a quality or laboratory setting.
  • Communicate effectively and foster teamwork and collaboration among a diverse team.
  • Demonstrate trustworthiness, reliability, ownership, and proactive learning.
  • Structure complex information, plan, prioritize, delegate tasks, and focus on deliverables.
  • Have excellent research, troubleshooting, and organizational skills.
  • Exercise judgment and work in a fast-paced environment.
  • Maintain working knowledge of applicable certification bodies and/or regulatory compliance requirements.
  • Maintain confidentiality when handling proprietary and sensitive documents and information.
  • Follow safety rules, maintain safety awareness, and participate in required safety training and meetings.
  • Participate actively in team and departmental meetings as requested to support efficient operations and continuous improvement.
  • Be able to stand for long periods and lift up to 50 pounds.
  • Wear masks, lab coats, and hair or beard nets in cGMP areas; makeup, perfumes, acrylic or artificial nails, and jewelry are not allowed in those areas.

Nice To Haves

  • Proficiency in Office 365.
  • Knowledge of current Good Manufacturing Practice requirements under 21 CFR Part 117 and Part 111.
  • Knowledge of the USDA National Organic Program and 7 CFR 205 as they apply to dietary supplement manufacturing.
  • Knowledge of allergen control programs and product safety as they apply to consumer product goods.

Responsibilities

  • Schedule training sessions, prepare training materials, provide training, or coordinate training with department heads; manage and implement the online training platform.
  • Maintain the training system database by entering records, tracking training, and preparing reports.
  • Create controlled document templates, including logs, forms, work instructions, and Standard Operating Procedures.
  • Participate in the design, development, and maintenance of Quality Management System documentation.
  • Track document status and communicate with involved parties during document review and editing.
  • Assist in verifying that documentation complies with current safety and GMP requirements.
  • Provide clerical support, including copying, scanning, retrieving, and filing electronic and hard-copy records.
  • Assist with scheduling routine mock recalls and evaluating related documentation.
  • Review and support technical documentation and commissioning activities.
  • Create Certificates of Analysis for all products.
  • Review product best-by-date reports for disposition and ERP updates.
  • Complete departmental activity reports as requested.
  • Maintain professional and technical knowledge by attending approved events.
  • Notify the Quality Management Team about Quality Management System issues or concerns.
  • Share process-improvement ideas with the Quality Management Team and others as directed.
  • Maintain a safe work environment by following companywide safety protocols.
  • Perform additional quality control tasks as required, including daily equipment, finished-goods, and freight-order quality checks.
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