Quality Assurance Specialist

POSITION SUMMARY:

The QA Specialist is responsible executing tasks associated with Quality Assurance activities surveillance programs such as CAPAs, complaints, stabilities, data trending and statistics, administration and review, internal/external audits and other defined tasks. The QA Specialist will continually evaluate opportunities for improvement to increase efficiency while ensuring compliance to applicable regulatory requirements and standards while supporting all quality programs, policies and procedures. This role requires the specialist to have the ability to produce results in a fast-paced environment to meet deadlines and to effectively prioritize based on criticality.

This position will require flexibility with work hours to cover for other team members when needed. The primary hours for this position will be 9am-5pm and willing to work overtime when needed.

ESSENTIAL FUNCTIONS:

• Responsible for leading efforts in the Quality Systems & Document Control programs, ensuring compliance to quality objectives and regulatory requirements.
• Communicate consistently and with a sense of urgency with different departments within the plant, to include but not limited to, human resources, maintenance, shipping / receiving, maintenance, warehousing, and production operations.
• Will interact effectively with many functions existing outside of a plant’s organizational structure to include, but not limited to, purchasing, technical services, research and development, product managers, and distribution center.
• Will interact with other entities outside the company structure: Examples include - customer visits, inspections, and audits as well as third party audits representing customers, pest control service providers, and testing equipment vendors / service providers.
• Responsible for customer complaint tracking and trend reporting.
• Responsible for Internal Audit and CAPA database for verification and effectiveness.
• Responsible for Change control request and deviation databases for effectiveness.
• Establish material traceability, and suspect material quarantine procedures.
• Provide audit support for third-party and internal audits.
• Lead or participate in the planning and implementation of process improvements, monitor improvement metrics and respond to unfavorable trends. Compile and provide applicable metrics for periodic Management review.
• Performs training for both new employees and ongoing training sessions for all departments. Ensure GMP training is effective in sharing GMP know-how needed to achieve best in class quality operations.
• Responsible for departmental non-conformances and implementation of corrective action ensuring all corrective actions are documented and outstanding actions closed in a timely manner.
• Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Assists the Quality Manager in writing and updating the Food Safety Plan, Standard Operating Procedures (SOPs), and other Quality Assurance documents as needed.
• Identify and participate in internal quality improvement initiatives, perform gap analyses and risk assessments, develop and implement improvements to relevant SOPs. Write, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Hold Accountable all supervisors/managers to train employees and perform operations per SOPs and cGMP
• Assists in preparing the annual management review, annual product reviews, food defense assessment and mock recall
• Oversee review and audit of various reports (Protocols, Qualifications, Regulatory Submissions, etc.).
• Follow up with implemented programs (GMPs, Good Hygiene Practices, HACCP, Allergen. Control, Cleaning and Sanitation, Pest Control, Equipment Calibration, Organic Certification, etc.) to ensure compliance by all employees and other personnel in the manufacturing facility.
• Share knowledge, skills and information with other personnel in the Quality Systems & Regulatory Compliance Department and across functional areas.
• Internal Auditing: Work with site operations team to develop and execute risk-based audit plans to mitigate quality risk.
• Creation and issuance of GMP logbooks/notebooks.
• Support update, review and approval of controlled documents, including procedures, work instructions, protocols, templates and technical documents.
• Monitors and verifies the HACCP plan, performs routine CCP’s verifications.
• Maintain Discontinuation Logs.
• Must exhibit initiative, a sense of urgency, and accountability.

REPORTING RELATIONSHIPS:

Critical Operating Relationships:

This position will report to the Quality Assurance Manager

QUALIFICATIONS:

Education:

• Bachelors / Associate Degree

Experience:

• Minimum 3-5 years’ experience in Quality Assurance for a Dietary Supplement and/or Food Manufacturing.

KNOWLEDGE, SKILLS AND ABILITIES:

• Excellent written and verbal communication skills
• Ability to multitask and have excellent time management skills.
• Have flexibility when new priorities arise and have a depth of knowledge in quality
• Strong interpersonal skills and management ability
• Detail-oriented
• Problem solving skills
• Able to use Microsoft Office
• Must work on “process level” and eventually “organizational level”.
• Perform a high level of review for all team members.
• Ability tocreate spreadsheets, excel sheets, writing documents, and configuring metrics.

OPTIMAL EXPECTATIONS:

This position requires a highly motivated individual with exceptional leadership and communication skills to help develop and lead culture of quality among the company’s employees, departmental leaders, and manufacturers. Hold team members accountable to ensure that actions and behaviors

• Hold team members accountable for the monitoring of processes during the manufacturing process.
• To communicate and report to manufacturing and management and do corrective actions when appropriate, deviations and defects when outside the specifications as directed in the Master Manufacturing record with a sense of urgency in real time.
• To initiate continuous process improvement and production improvement on fact based feasibility studies and report to management.