SQA Manager

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

PRIMARY PURPOSE:

Seeking SQA (Supplier Quality Assurance) Manager with knowledge and skills based on cGMP, CFR, ISO, and/or FDA experience. You will assist in revising and

enforcing the Formulated Solutions Quality System utilizing principal techniques and procedures to assure product quality and regulatory compliance.

MAJOR DUTIES AND RESPONSIBILITIES

• Follow all safety and cGMP procedures.
• Conduct and Manage Investigations/CAPAs according to Formulated Solutions SOP.
• Follow-up on corrective actions and audit findings to verify compliance status.
• Coordinates with Warehouse Management, Lab Manager, Pre-Weigh/Blending Management, Production Management
• Manages and directs the Incoming Inspection and Raw Material Sampling processes to meet the needs of the production schedule for Pre-Weigh, Blending, and Filling alike by ensuring that the flow of materials received are being sampled and delivered to their respected groups within a timely manner.
• Coordinates with the Lab Manager to direct the QC Analysts and Data Reviewers for adherence to the schedule and ensure the testing process from the lab standpoint is upheld as well as coordinate the release of raw materials and bulk intermediates as needed for production use.
• Manages and coordinates the transportation of samples needed to be delivered to the lab for testing.
• Coordinates with the Warehouse Supervisor/Manager to assess and ensure the material movement required for Raw Materials as well as Component samples to be pulled and inspected.
• Coordinates with the Production Management group to assess the components needed for the production floor use.
• Coordinates with Blending and Pre-Weigh management to assess the materials needed to maintain the schedule.
• Coordinates and Manages the logging, inspection, and upkeep of the retains for finished product, intermediate, and raw material retains.
• Skill in interpreting and applying product specifications, technical data, regulations, policy statements and other guideline materials.
• Demonstrates skills in conducting studies and investigations, problem analysis, and developing logical and documented recommendations.
• Make changes to internal Formulated Solutions SOP/documents/procedures, as necessary.
• Promote continuous improvement and customer satisfaction.

QUALIFICATION:

Experience working in a Quality Assurance and/or Quality Compliance role.

• Ability to follow detailed procedures/SOP and maintaining accurate records.
• Experience in an FDA-regulated industry (i.e. pharmaceutical/medical device).
• Knowledge of FDA and cGMP manufacturing guidelines.

CRITICAL SKILLS AND ABILITIES:

• Knowledge of Quality Assurance/Control methods, principles, and practices based on cGMP, CFR, ISO, and/or FDA recommendations. As well as knowledge of the relationship of Quality Assurance to other activities such as production, engineering, purchasing, and/or warehouse activities.
• Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and produce reports.
• Ability to make quality decisions and act accordingly.
• Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
• Ability to perform effectively under conditions of fluctuating workload.
• Ability to handle and resolve recurring problems.
• Communicate with others clearly and concisely.
• Ability to work in a fast-paced environment – sometimes rapidly shifting priorities
• Ability to concentrate in such an environment and perform quality work.
• Strong initiative, technical commitment and contribution to company and departmental goals

COMPUTER SKILLS:

• Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and compile reports (i.e. Microsoft Office).

EDUCATION AND/OR TRAINING:

• Degree in technical science or chemical sciences and a minimum of two years experience working in an FDA regulated pharmaceutical or medical device environment. If no degree, or equivalent work experience: at least five years working in an FDA regulated pharmaceutical or medical device environment.