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).
Job Title: Quality Assurance Associate (Product Release)
Department: Quality Assurance
SUMMARY
This position supports the different activities within the Quality Assurance Department. Incumbent is responsible for review of intermediate batch records and autoclave runs. In addition, incumbent serves as backup for document control activities and record entry and maintenance of the training system. Also participates in projects within the QA/RA departments.
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 for these activities.
Serve as a backup for Master Filing Maintains Hardcopy Master Files up to date. Distributes new documentation and retrieval of out dated reference copies, and files the original documentation.
Serve as a backup for Administration and Maintenance of the Quality System documents Issuance of lot numbered documents and forms for manufacturing, quality control and other departments on a weekly basis. Performs archiving and Device History Record filing, Off-Site storage program. Filing and Handling of QA/RA document maintenance activities.
Collaborate with different members of the QA/RA Department working in special projects.
Additional assignments as directed by Supervisor.
SUPERVISORY RESPONSIBILITIES
Position has no supervisory responsibilities.
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
Associate’s degree from a two-year College; or one to two years related experience and/or training; or equivalent combination of education and experience. Associates Degree preferred.
KNOWLEDGE AND SKILLS / ABILITIES
Requires strong personal computer skills Keyboarding, 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 customer service activities / 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 preferred.
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 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.
PHYSICAL DEMANDS
Position requires incumbent to work with personal computers performing keyboarding / typing and data entry. Extensive filing required. Some lifting of boxes is necessary.
Please review our website at www.advancedbiohealing.com for more company information.
We offer a competitive benefits & compensation package!
All qualified resumes should be submitted directly to careers@advancedbiohealing.com
We are an Equal Opportunity Employer.