Senior Quality Engineer

 

Department:  Quality

Reports To:    Quality Director

 

Job Summary:

The Senior Quality Engineer will be responsible for identifying, raising and resolving quality issues to ensure zero impact to the customer. Responsible for developing and implementing effective Quality strategies and methods. Working closely with the Quality, Operations, R&D Teams to fulfill quality and regulatory requirements. Responsibilities included but not limited to providing full QA support for implementing and maintaining compliance to Current Good Manufacturing Practices (cGMP), Quality Standards at Contract Manufactures and vendors with establishing and maintaining quality protocols and quality culture within the Department and Colorescience Inc. This position interacts with higher level management, contract manufacturers, partners, and suppliers. Manage internal and external partnerships to ensure efficiency and performance standards are achieved.

 

Essential Duties and Responsibilities:

Manage and comply in a team environment with the Company’s Quality System to ensure compliance with cGMP requirements. Ensure quality and regulatory compliance with applicable regulations (ex. ICH, CFR21-Part 211, cGMP) Responsible for the daily oversight of the CMOs, vendors, in accordance with product risk profile, oversight the accountability included but not limited to supplier audits, supplier evaluation re-evaluation, corrective action management, and the facilitation and implementation process improvement project. Qualify, evaluate the operation of CMOs and Quality activities in relation to compliance with Quality Standards and Regulations and recommend where corrections or improvements are necessary. Provide direct support to Quality Management/Quality Personnel regarding operation of the department and Quality System. Ensure that CS products are consistently manufactured in accordance with Tech Files, Dossiers, Specifications etc. Support product release process to ensure compliance to product specifications, domestic and international requirements. Drive the operation of the Quality System process related to Corrective/Preventive actions and product non-conformance control including capturing data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting. Coordinate/Execute in the team environment the operation on Internal and external Audit System. Provide leadership as required while conducting all such audits. Provide leadership in directing and promoting the Quality Improvement process. Support the company’s Adverse Events (AEs) and Products Quality Complaints (PQs), implementing corrective measures. Support Document Control function, SOPs, Product Specification. Oversee and coordinate Quality Training. Assure regulatory compliance to Local, State, Federal, and International Regulatory agencies. Hands on support in manufacturing and testing product validation programs, product stability program, overseeing their implementation to ensure that reliable and repeatable processes for manufacturing, filling, packing, and testing are properly executed, and implemented. Support the Annual Drug Review (ADR) process, assess manufacturing and testing trends and corrective measures when required.

Education and/or Experience

Demonstrated technical expertise in, and understanding of cGMPs, CFR21- Part 210 & 211, ICH guidelines and regulatory and audit requirements. Bachelor's degree with preference in the science/chemical engineering field with at least 5 years’ experience in Quality Engineering role in the pharmaceutical/cosmetic industry with knowledge throughout the product manufacturing and testing cycle. Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines. Proven ability to develop and maintain relationships with internal and external customers, suppliers, partners, and other stake holders. Demonstrated knowledge in working with contract manufacturers, API, and primary component suppliers. Experience with pharmaceutical/cosmetic/ manufacturing, laboratory testing, quality control/assurance and regulatory affairs. Experience with topical OTC regulated products preferred. Proficiency and expertise in Quality software’s and, Microsoft platforms, (Word, Excel, and PowerPoint) is a requirement.

Skills and Abilities

Thorough understanding of, manufacturing, quality control, quality assurance (audit) and regulatory issues related to OTC regulated topical products.

Excellent people and communication skills are a core competency for this position.

Proven record of working with CMO partners to achieve Quality standards.

Strong technical, analytical skills to dissect complex systems, identifying problem areas, and advice effective strategies.

Knowledge and experience with analytical testing, manufacturing, and packaging operations.

Ability to adjust to company “Team Culture”, to work and communicate effectively through the organization.

Ability to work independently as well as collaborate effectively in a TEAM environment with various technical area experts.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is required to stand and walk. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet.