Syndel – QA Manager

FLSA: Exempt

Role: Manager

About the Job:
Come ready to explore and you will find a place where your talent takes flight—beyond the borders of title, a country, or your comfort zone. Bring your passion and commitment and we will welcome you into a tight-knit team that takes our mission personally. Channel your drive to make a difference into shaping Syndel, a global leader in fish health solutions, and an industry that is evolving fast to meet the needs of the future.

Innovation through diversity of thought:
Within the Quality Department at Syndel, we believe diversity of thought enables creativity, innovation, and a foundation for inclusion. By fostering an inclusive culture, we accept a shared accountability and responsibility to recognize, sponsor, coach, hire and promote talent equally. We welcome our employees to be their whole - best - selves at work because trust, respect, and integrity, are a part of our DNA.

Responsible for:

• This position will provide support to the Syndel Quality team in the post implementation activities associated with an electronic Quality Management System (ZenQMS) used in an FDA regulated Good Manufacturing Practices (GMP) facility.
• Perform the duties of a ZenQMS SuperUser as required.
• Assist in authoring/updating Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs) and Forms.
• Initiate Deviations, Corrective Action & Preventive Action (CAPAs) and Change Controls as required.
• Lead annual GMP training for the company.
• Perform Annual Product Quality Reviews (APQRs) for regulated products.
• Initiate and maintain Quality Agreements (technical agreements) with suppliers/vendors.
• Assist the QC Officer with tasks related to oversight of Packaging/Labelling, batch record review and product release.
• In charge of the Vendor/Supplier Management Program and maintain list of Approved Vendors.
• Review of training records to ensure completeness.
• Perform Bi-Annual Data Integrity Review of lab instrumentation.
• Perform Internal Audits as required to analyze quality compliance and assess risk.
• Support Management Review activities and oversee trending of key quality, product and GMP metrics.
• Support regulatory inspections and external audits from partners.
• Maintain Quality Manual & Site Master File.
• Perform Warehouse Temperature Mapping in Winter & Summer.
• Manage maintenance of Temperature Loggers.
• Provide Quality Assurance support across departments/functions such as Manufacturing, Supply Chain, Warehouse & Packaging, Quality Control and Regulatory Affairs.
• Create and execute validation deliverables such as Validation Plans, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Complete other essential Quality Management System (QMS) tasks as assigned.

Job Qualifications
• College degree or equivalent experience.
• Minimum of five (5) years of previous pharma industry experience using the following QMS modules: Document Control, Training, Deviations and CAPA.
• Subject Matter Expert (SME) in Good Documentation Practices & Data Integrity.
• Knowledge of Risk Management.
• Experience with auditing vendors/suppliers by performing paper audits or video audits.

Skills Required
• Microsoft Office Suite (Excel, PowerPoint, Outlook & Word).
• Ability to contribute to a positive work environment by behaving and communicating in a manner that works positively with co-workers and management.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Experience as a people manager is a plus.