Director of Quality Assurance

Unlimited Futures, Inc.(UF) is a manufacturer of wipes products, including prescription wipes, that require controls and oversight to ensure these products meet FDA quality guidelines. 

 

Director, Quality Assurance

 

Primary Responsibilities:

? Ensures that all manufacturing operations meet quality and cGMP standards, and that all CMC requirements are being met. 

?  Manages the analysis, release (according to specifications) and documentation of all incoming raw materials and components.

?  Monitors the adherence of processes to the batch sheet and that batches are documented properly.

?   Manages the analysis, release and documentation of final packaged goods.  When required, authors process deviation reports.

? Maintains, in agreement with clients, a database of product specifications (including incoming raw materials/components, as well as finished goods).

 

? Determines training needs and conducts training as needed for all personnel regarding QA (equipment training, hygiene/attire training, safety training, etc.).

 

? Maintains all Document Control activities (e.g SOP?s, specifications, etc) with timely review.  Adds and deletes SOP?s as appropriate.  Assures that UF is following SOP?s at all times.Maintains all validations, process, cleaning, facility, etc, for all operations at UF and/or sub-contractors.

 

? Coordination, compilation, submission and maintenance of all registrations required by FDA (NDC drug listings, etc.) for products being produced at UF, including annual reporting requirements

? Maintains current knowledge of QA standards. Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.  Is prepared to represent UF during FDA audits, including review of all materials requested, and preparation/execution of action plans.  Maintains a relationship with local regulatory authorities (FDA, EPA).

? Recognizes and reacts to product and process quality problems, leads problem-solving initiatives and recommends/oversees corrective action.  Manages responses to customer complaints and inquiries, including maintaining and analyzing frequency and types of issues raised, OOS investigations, and action plans.

? Monitors and ensures compliance with company policies and procedures.
 

? Makes and executes operational decisions with a strategic perspective.

 

Requirements:

 

? B.S. degree (chemistry preferred or other technical degree) with a minimum of five years experience in pharmaceutical quality assurance. 

? Prefer the candidate have experience with wipes products, but not mandatory.