As a member of the Quality Assurance Team, this position will help determine disposition of final product and ensure compliance with Quality Assurance (QA) policies and procedures, cGMPs and SOPs.
Summary of Essential Job Functions
- Quality system management and oversight for non-conformance events, change control, corrective and preventative actions (CAPAs) and standard operating procedures (SOPs).
- Analyzes, evaluates, presents and escalates to management, any identified risks, improvement opportunities and/or compliance concerns associated with Healthpoint’s quality systems. (Focused on Deviation, Investigation and CAPA systems).
- Provides backup quality systems support for the Change Control and Product Complaint systems.
- Supports QA in the timely implementation, assessment and closure of product related projects and operations.
- Contributes to a motivating work environment, where superior performance is defined, supported, rewarded and recognized.
- Follow up on and drive to closure the formal investigations in response to Out-of-Specification (OOS) events; prepare and evaluate CAPA responses.
- Review and approval of incoming raw materials, finished product batch records & lab data and perform periodic product reviews.
- Bachelor's Degree in Science or applicable field with 2 to 4 years of QA.
- Must have Pharmaceutical (clinical, pharmaceutical, biopharmaceutical, consumer healthcare, vaccines) experience supporting manufacturing operations to include a variety of the following: batch record review and approval; lot release; non-conformance investigation process; CAPA; change control; validation method and protocol review and approval, SOP review, writing and approval.
- Demonstrate a technical understanding and knowledge of pharmaceutical facilities, equipment and quality systems.
- Demonstrated knowledge of GMP’s, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
- Excellent computer systems and MS Office skills with working knowledge of computer relational databases.
- Working knowledge of TrackWise and Crystal Reports highly desirable.
- The ability to effectively build and maintain relationships within a highly matrix team in order to effectively negotiate and solve problems.
- The ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
- The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
- The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
- The ability to maintain an attention to detail while executing multiple tasks.
- The ability to exhibit flexible thinking.
- A continuous improvement and quality mindset and a willingness to develop yourself and others.
Healthpoint Biotherapeutics is committed to conducting business in an ethical manner and it is our expectation that the individual in this role will ensure compliance with all applicable laws, regulations, procedures and Healthpoint’s Core Values. Healthpoint is in a highly regulated industry and, as a part of this role, this individual will be required to understand how compliance is integrated within their daily activities and perform in their role with a high level of integrity.”
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Healthpoint Biotherapeutics, a Smith & Nephew business, is an Equal Opportunity Employer.
Healthpoint - 16 months ago