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 Specialist I (Document Control)

Department:      Quality System & Quality Assurance   

SUMMARY

This position is responsible of the day to day operation of the Document Control function.  Incumbent is responsible for change incorporation, master filing activities and change administration requirements for product documentation and labeling.  Device Master Record and Device History Record file maintenance.  In addition, performs process improvements within the Document Control Area.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Change Administration – Screens Change Orders (COs) for completeness and accuracy.  Prepares CO packets for review, tracks COs through the review and approval process and coordinates incorporation of approved changes.  Incorporates approved changes / “redlines” to documentation.  Supports Change Control System metrics to allow for monitoring of trends, etc.


• Administration and Maintenance of the Quality System documents – Ensures authorizations are maintained for Change Control Board (CCB).  Maintains change/revision history, Device History and Device Master Records, Area Reference copies, Oversees Periodic Review documentation, filing and archiving activities.  Manages Off-Site Storage Program.


• Master Filing – Produces “original” documentation, verifies the correct incorporation of changes, updates Device Master Record as applicable and verifies master filing activities.  Maintains Hardcopy Master Files up to date.  Distributes new documentation and retrieval of outdated reference copies, and files the “original” documentation.


• Customer Service Activities – Interdepartmental copy requests, internal customer inquiries, expedition of interdepartmental copy requests, support interdepartmental research / investigation activities.


• Additional assignments as directed by Supervisor.


• Collaborate with different members of the QA department working in special projects.


• 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.


• Schedules periodic review and coordinates with the different responsible departments to ensure compliance.


• Maintains the training system.  Enter training records, update training matrices and create new files for new employees in the database.


• 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

Bachelor's degree from a four-year College and 1 years of experience in a Document Control GMP work environment; or four to two years related experience and/or training; or equivalent combination of education and experience.  Bachelor’s Degree in a scientific discipline preferred.

KNOWLEDGE AND SKILLS / ABILITIES

• Requires 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.


• Knowledge of electronic document systems.

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.