Quality Assurance Specialist II, Product Release

Advanced BioHealing (ABH) is a specialty biotechnology company focused on the development and marketing of cell-based and tissue-engineered products. We are a privately held company with two approved products: Dermagraft® and TransCyte®. Our development pipeline also includes a next-generation bioengineered wound therapy for which two Investigational Device Exemption (IDE) applications have been approved by the Food and Drug Administration (FDA).

We currently have an opening for a Quality Assurance Specialist II (Product Release) at our La Jolla, CA manufacturing facility.

 

This position is responsible of the day to day operation of the Product Release function.  Incumbent is responsible for reviewing final product batch records, intermediate batch records, and autoclave runs.  Maintains metrics of the Product Release performance on a monthly basis.  In addition, performs process improvements within the Product Release Area.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.Perform Final Product Batch Record review and release.  Maintains metrics to demonstrate up to date status of progress and monthly performance.  Interacts with the Manufacturing Department to resolve issues related to the review process.Perform Batch Record review of Intermediate Batch Records, and Autoclave Runs as needed.  Responsible for training personnel to serve as back up for these activities.Prepares quality training modules focus on company’s needs and feedback from the review process.Collaborate with different activities related to Document Control to serve as back up.  Such as Master filling and verification activities, among others. Collaborate with different members of the QA/RA Department working in special projects.Additional assignments as directed by Supervisor.



QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor's degree from a four-year College and 3 years of experience in a Product Release GMP work environment; or five to three years related experience and/or training; or equivalent combination of education and experience.  Bachelor’s Degree in a scientific discipline preferred.

KNOWLEDGE AND SKILLS / ABILITIESRequires strong computer skills, Microsoft Office Applications (Access, Excell and Word).Must be detailed oriented, be able to follow detailed instructions, possess excellent time management skills, be well organized, a self starter and display a professional demeanor wit a high focus on quality, compliance, and responsibilities.Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date; ability to closely monitor and communicate progress on daily tasks and responsibilities to Management.Must be able to work as a team member, maintaining day to day activities while being responsive to changing priorities.Verbal communication skills (English)Knowledge of Good Manufacturing Practices / Quality System Regulations and ISO Standards required.Must be able to work a consistent schedule to satisfy the responsibilities of the job.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general business procedures, technical procedures, or governmental regulations.  Ability to write reports and procedures.  Ability to effectively present information and respond to questions from groups of managers, and employees of the organization.

MATHEMATICAL SKILLS

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.  Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

REASONING ABILITY

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Ability to deal with problems involving several concrete variables in standardized situations.

PHYSICAL DEMANDS 

Position requires incumbent to work with personal computers performing keyboarding / typing and data entry.  Extensive filing required.  Some lifting of boxes may be necessary.

 

We offer a competetive benefits & compensation package.

 

All qualified resumes should be submitted directly to careers@advancedbiohealing.com .

 

We are an Equal Opportunity Employer.