QA Document Control Manager

Position Description Position Title: QA Document Control Manager FLSA: Exempt Position’s Manager: QC Manager Department: Quality WHAT YOU’LL DO (MAJOR RESPONSIBILITIES): Coordinate document control of QA core documents (i.
e.
, MMR, BPRs, CAPA’s etc) Carry out investigations of deviations and complaints received on all products Monitor Temperature and Humidity of manufacturing facility as well as offsite warehouses and create monthly trend reports Process and disposition product returns in a timely manner Perform environmental monitoring of production facility as designated by QC Manager In-Process monitoring and performance of Quality Verifications during Production runs Compile Finished Product COA’s across all brands for Management review.
Provide copies of CofA’s as requested to support product sales in channels and markets Performs complex data analysis in support of customer requests.
Responsible for data collection to identify baselines and process measures, management of report distribution on a regular basis and continuously recommends changes based on identified best practice.
Turns data into information and proactively identifies opportunities based on that information.
Partners with QC Manager to align priorities, deliverables and assist in the development of system-wide analytics and support for the organization around improvement initiatives, process improvement and data mining Issue deviations and conduct material reviews with the oversite and approval of the QC manager Accountabilities include data entry, report development, preparation, and routine system management.
Participates in planning and standardization of processes within the QC department Controlling and inspecting facility logs and documentation As designated by QC Manager helps with approval/rejection of all raw materials, packaging materials, finished products, GMP-related documents, labels, forms, laboratory test results, and material specifications Sampling and sample preparation of Raw Materials and Finished Products for contract laboratory use Responsible for following standard operating procedures and related systems that ensure company compliance and applicable regulations.
Maintains all SOP documents and tracks SOP training completion across the company Performs all functions necessary as required by management to complete the job WHAT YOU’LL NEED (KNOWLEDGE/SKILLS/EXPERIENCE): BS, or MS in Chemistry, Biology, Nutrition, or related science Minimum 5-7 years’ experience in FDA regulated Quality Control environment including QA documents for manufacturing (Master Manufacturing Records (MMR) and Batch production Records (BPRs) and reviewing deviations) Significant knowledge and training in cGMP’s Ability to work and ensure compliance in a GMP environment Ability to work with required documentation and give the necessary attention to details Ability to absorb quickly and use on the job training Ability to work independently and function at a high level Ability to effectively work with all members of the staff Ability to coordinate problem-solving from various departments Ability to follow written and oral instructions and be a team player Ability to issue, use, and maintain written records PHYSICAL REQUIREMENTS: Standing, walking and sitting while working on a computer Blueroot Health™ is an Equal Opportunity Employer.
Employment opportunities at Blueroot Health™ are based upon one’s qualifications and capabilities to perform the essential functions of a particular job.
All employment opportunities are provided without regard to race, religion, sex, national origin, age veteran status, disability, genetic information, or any other characteristic protected by law.
This Equal Employment Opportunity policy governs all aspects of employment, including, but not limited to, recruitment, hiring, selection, job assignment, promotions, transfers, compensation, discipline, termination, layoff, access to benefits and training, and all other conditions and privileges of employment.