QA Coordinator, Contract - (X076)

QA Coordinator, Contract - (X076)

12 Jul
|
Jamieson Wellness
|
Windsor

12 Jul

Jamieson Wellness

Windsor

International Nutrient Technologies is a subsidiary of Jamieson Wellness. (This contract is until December 2022 or until the incumbent returns) 1. OVERALL RESPONSIBILITIES: The QA Coordinator will support all Quality Systems to ensure quality manufacturing of products as defined by current Good Manufacturing Practices (cGMP). Provide assistance to other departments concerning quality and GMP issues. Ensure appropriate compliance to all relevant regulatory requirements. Accountable for timely release of bulk softgel capsule products to cGMP standards. 2. DUTIES AND RESPONSIBILITIES To act as a qualified person (as defined under Health Canada section C.02.006 of GMP guidelines) in the release of finished product.

To work in a team environment with other QA Coordinators to ensure all job functions are covered. To assist in preparing documentation for external customer and government audits. To audit batch records and approve final release of finished products. To perform production batch adjustments and one-time-spec changes as required. To provide assistance for other departments concerning quality related issues. To issue rework/reclaim masters as required. To coordinate and/or perform formal AQLs and carton AQLs as required. To maintain internal audit program by organizing and leading internal audits and follow-ups. To maintain up-to-date and accurate Quality tracking database entries including deviation investigations, foreign capsules, complaints, change control, CAPA, SOPs, training, reworks, reclaims, etc. To investigate non-conformances, deviations or complaints including conduct root cause analysis, trending and implement CAPA plans as required. To prepare, revise or approve master batch records and specifications. To review product formulas entered in production masters and into QAD manufacturing software program.

To create, review or approve change requests as required. To maintain SOP system including organization of SOP files, preparation of SOPs into the proper format, issuance, tracking and filing of employee SOP training and distribution of authorized SOPs. To create, revise and control form templates. To conduct new hire GMP orientation training. To issue and track employee training and maintain employee training files. To maintain quality departments controlled document files. To review and file applicable production logs/facility records including calibration, equipment, facility, temperature/RH, maintenance, PCO pest control, and sanitation. To organize, file, retrieve and maintain batch record archives, product master files and raw material files.

To photocopy documentation requested by third party customers and internal company personnel and track requests. To perform/review qualifications of raw materials, vendors or contractors as required. To conduct APRs as required. To conduct Validation documentation reviews as required. To populate Quality Metrics such as Quality System Trending (QST), QPIs, WIP as required. Maintain daily DSC schedules and reporting. Prepare Technical Documents (ie. RCA root cause analysis reports) and Study Protocols as required. Other duties and projects as required. 3. QUALIFICATIONS AND BEHAVIORAL REQUIREMENTS: Minimum Bachelors Degree in Science related field from an accredited post secondary institution. Minimum 2 years practical Quality department experience in a pharmaceutical, nutritional, food or health products manufacturing environment. Comprehensive knowledge of manufacturing operations and cGMP.

Experience in softgel manufacturing environment an asset. Comprehensive knowledge of pharmaceutical, food and natural health product regulations. Excellent communication skills. Excellent problem solving skills. Proficient with computers. Experience with manufacturing and inventory management software, LIMS software systems, and other Quality Systems database systems an asset. Team oriented focus. Self-starter and critical thinker. High work ethic standards a must. Ability to work with minimal supervision. Able to work shift work to provide job coverage as required. Able to work overtime to meet production/customer deadlines and complete projects in a timely fashion as required. HOW TO APPLY: All those interested in applying for this job posting may do so by submitting an application to the Human Resources Department by the closing date noted above.

All full-time and part-time employees are eligible to post for the said position. Previous work history will be considered in the final selection. INTL is an Equal Opportunity Employer and welcomes and encourages applications from all interested and qualified candidates. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, INTL will provide accommodations throughout the recruitment, selection and/or assessment process to applicants with disabilities. If selected to participate in the recruitment, selection and/or assessment process, please inform INTL Human Resources staff of the nature of any accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.

The original job offer can be found in Kit Job:
https://www.kitjob.ca/job/32231112/coordinator-contract-x076-windsor/?utm_source=html

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