Sr QA Product Release Associate

At MIMEDX, our purpose starts with helping humans heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care & surgical products, we are committed to making a transformative impact on the lives of patients we serve globally. Will you join us on this journey?

We are excited to add Senior QA Product Release Associate to our Quality Assurance team! This role will be a hybrid position. The position will pay between $18.00-28.00 per hour based on previous relevant experience and educational credentials.

POSITION SUMMARY:

Will review documentation of actual process performed in the manufacture of any/all products to ensure compliance with all standard operating procedures (SOP's) and applicable regulations. Inspect all new products and determine their acceptability for release for distribution/shipment; inspect returned products to make final disposition determination. Work to resolve identified errors and deviations, review and maintain applicable records, and ensure compliance with quality system standards, policies, and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review documentation records within the CEA completed by technicians during processing of any/all products to ensure proper procedures were followed
• Identify any errors/deviations in processing records and work with appropriate individual(s) to resolve, and/or submit for review/approval as needed
• Inspect final products identified as ready for release by packaging technician to determine acceptability for distribution and shipment (e.g. product is in proper packaging, correct label, untampered safety seal, etc.); compare documentation records to visual inspection of product
• Inspect the condition of all returned products and determine final disposition (e.g. can it be returned to inventory, does it require re-packaging, should it be discarded as waste, etc.)
• Identify any issues with returned products (e.g. wrong quantity received, opened packaging, etc.; notify management and customer service (who processes returns)
• Review quality control records to ensure accuracy and acceptability of analytical results including product moisture levels, and out-of-specification investigation documentation, as applicable
• Make final determination of product availability (new and returned goods) for use; move product both physically and electronically (e.g. inventory database) from packaged goods quarantine room/returned product quarantine to release product storage room
• Communicate inventory levels related to newly released new product and/or returned products to fulfillment departments (i.e. operations, shipping/storage)
• Reconciliation of processing records for technician documentation of donor processing
• Review autoclave logs, equipment maintenance records including environmental monitoring results, and cleaning logs, etc.
• Manage the transfer of completed, hard copy processing charts and donor records to quality assurance storage areas across different company's facilities; help with inventory activities of all records prior to shipment to off-site storage facilities for record retention and tracking purposes
• Perform customer validations by verifying product shipping addresses are compliant with regulatory requirements (i.e. being shipped to freestanding healthcare facility); communicate non-compliant issues to customer service
• Ensure company-wide compliance to quality system standards and procedures; identify, recommend, and assist with the development and implementation of needed improvements

PROBLEM SOLVING:

• Effectively identifies problems as they occur and takes appropriate steps to solve them in situations where the problem is not difficult or complex
• Refers complex, unusual problems to supervisor

DECISION MAKING/SCOPE OF AUTHORITY:

• Under general supervision, exercises some judgement in accordance with well-defined policies, procedures, techniques
• Work typically involves regular review of output by a senior coworker or supervisor

SPAN OF CONTROL/COMPLEXITY:

• Fully functioning support role having greater responsibility to perform all (or most) of the standard work within the function; moderate impact to the department

EDUCATION/EXPERIENCE:

• Bachelor's degree in related field or equivalent work experience
• Specialized skill training; certification may be required
• Prefer knowledge of AATB, FDA, and other state/federal regulations

SKILLS/COMPETENCIES:

• Excellent oral, written, and interpersonal communication skills
• Proficient in Microsoft Office (Excel, Word, etc.)
• Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail
• Must show aptitude to develop appropriate skills needed for the job

WORK ENVIRONMENT:

The work is typically performed in a normal office environment, processing lab or warehouse. Role routinely uses standard office equipment; may require use of lab equipment (i.e. refrigerator). Will be required to comply with proper protective equipment guidelines (e.g. gloves, masks, lab coats, etc.), as applicable.