Quality Process Compliance Specialist

MeriCal•Anaheim, CA

11d

About The Position

The Quality Process Compliance Specialist will ensure that the facilities are operating per cGMP requirements and internal Merical procedures. Ensuring records prepared by manufacturing, Quality Control, Maintenance, Warehouse, etc. meets all established criteria, completed in real time while following Good Documentation Practices. Ensure quality assurance programs are maintained in accordance with pertinent regulatory requirements and internal SOPs in the performance of the duties of this position. It is also responsible for reporting KPI, performing internal audits, customer complaint investigations and reports necessary to support these programs. This role will be critical in performing or coordinating the updating of procedures, process documentation and collaborating with multiple internal departments to ensure regulatory compliance is maintained or exceeded within Merical. The quality process compliance specialist should develop, implement, and administer required certification programs requirements internally with the internal stakeholders i.e.: R&D and Procurement.

Requirements

Bachelor's Degree in Food Science or equivalent is required.
Minimum of 8 years in FDA Regulated Manufacturing environment.
Critical thinking abilities with self-motivation to dive into details as needed.
Must have working knowledge of industry regulatory compliance standards FDA 21 CFR Parts 111(Dietary Supplements), 117 (Human Food) or 210 and 211 (Drug Manufacturing).
The specialist must have a broad knowledge of 21 CFR Part 111 Current Good Manufacturing Practice
Must be proficient in MS Office (Word, Excel, PowerPoint, Visio, MS Teams), and Adobe Acrobat.
Must be organized, meet deadlines and tasks, prioritizing efficiently and creating a workflow for the process.
Excellent communication skills: Must read, write, and understand English to communicate at various organizational levels.
Demonstrates flexibility when confronted with urgent situations, priority changes, or new assignments.
Accept other additional assignments and responsibilities to support the business.
Ability to work independently and manage time effectively and/or work cross functionally with other departments.
Self-driven & motivated.
The specialist must have strong leadership and communication skills and have the ability to tackle problems as they arise with limited supervision.

Nice To Haves

PCQI Certified, a plus.
Expertise with 3rd party compliance certification bodies/standards (Organic, Kosher, Halal, Non-GMO) a plus.
Knowledge of local, state, and federal regulations applicable to the plant’s business is desired.
Internal Auditing of dietary supplement manufacturing and an understanding of HACCP are desirable.

Responsibilities

Applied knowledge of Parts 111, 117, 210/211 of the FDA Code of Federal Regulations (e.g., HACCP, and Risk-Based Preventative Controls for Human Food, FSMA, FSVP, cGMP), and regulatory matters in other jurisdictions (e.g., Health Canada).
Working with internal department heads, leaders, and floor personnel, to ensure compliance with Regulatory, 3rd party and Merical requirements, driving process and documentation improvements to ensure requirements are met or exceeded across multiple sites.
Leads product complaint investigations, responds to customer, and ensure closure <30 days, tracks, and trends.
CAPAs, and SCARS review, process, and initiate.
Maintain all logs related to these processes.
Review calibration results and document the review, support maintenance with updating the master calibration list in the maintenance software program.
Supports FDA Recall/Withdrawals: Research, Submission, Monthly Effectiveness checks, updates to FDA, CAPA, and Customers.
Assist in coordinating with production and planning schedules to ensure batch records are issued to the floor prior to production needs.
Conduct internal audits to verify compliance with regulatory, cGMP, food safety, and company requirements; monitor established programs and collaborate cross-functionally to implement improvements as needed.
Perform required training of personnel on procedures, processes, regulations, corrective actions and new procedures.
Support QC Inspectors on manufacturing and packaging as needed.
Write, edit, and update company policies and procedures.
Supports and participates in inspections and audits from State, Federal, 3rd party certifiers, and customer inspection.
Monitoring and reporting of Quality KPIs.
Analyze data and provide solutions to improve quality and efficiency.
Perform troubleshooting and investigation of process non-compliances.
Initiates, documents, routes, and approves non-conformances, deviations, CAPAs, and change control documents.
Develop or update validation/verification protocols.
Works to complete annual reviews of HACCP Program, audit findings, update flow diagrams in Visio, and document reviews via summary Reports.
Review and approve the supplier qualification package prior to final supplier approval and conduct periodic reviews of suppliers considered high-risks.
Prioritize tasks in a high-pressure and deadline-driven environment.
Completes requests from Contract Customers for: Pre-Audit questionnaire completion, GMP Certs, Licenses and Registrations etc.
Works periodically on the manufacturing floor to support in-process inspection, AQL and sampling.
Oversee and coordinate facility and equipment change controls, assisting in equipment qualification reporting and execution.
Author and review quality report; Annual product reviews, quality risk assessments, impact assessments.
Performs other duties as assigned.