On-site in Miami
Biologics Company
$70k-$80K
**2 years experience in QA as a Manager, Supervisor, or Team Lead**
**Must reside in the US and be willing to be in the Miami/Ft Lauderdale area**
Reports to the Director, Quality Assurance
5 Direct Reports
Overview
Manage the overall operation of the Quality Assurance (QA) process, including Donor Eligibility Determination and Final Release of product. Ensure that all donor and batch release responsibilities are performed in accordance with current Standard Operating Procedures and in compliance with federal, state, and local regulations in addition to pertaining accrediting agencies. Manages the continuous review and inspection of donor chart records ensuring the medical record documentation and processing record documentation are assembled compliantly, reviewed and completed in a timely manner. Communicate and coordinate effectively with other departments to meet production and sales needs. Prepare and report on functional area metrics.
Requirements
- Bachelor’s degree in a medical or science-related field is preferred.
- 2 years of experience in Quality Assurance in a Pharmaceutical or biomedical industry or related
- 2 years of experience as a lead, supervisor, or manager in QA
- Excellent interpersonal, telephone, verbal and written communication skills required
- Must have technical writing skills
- Must have experience supervising staff in a manner conductive to top performance and high morale.
- Must be detail-oriented, organized, accurate, and able to multi-task, problem-solve and give recommendations.
- Knowledge of Good Manufacturing Practice and Good Tissue Practice regulations preferred.
Responsibilities
- Ensure compliance including AATB standards, FDA regulations and applicable state requirements.
- Maintain knowledge of all QA procedures and processes related to tracking systems, current donor acceptance criteria, donor eligibility determination procedures, batch release procedures, and assists in their review and development.
- Develop, maintain, and report to senior management performance and release metrics.
- Develop and maintain tracking mechanisms for donors shared with partner agencies to ensure timely chart review and release. Provide reports to senior management when requested.
- Attend weekly planning meeting as the Quality Assurance representative and work with Operations, Customer Service, Distribution, and all other cross functional departments to ensure commitments and customer needs are met.
- Complete nonconformance and corrective and preventive action reports as needed. Support investigation and completion of complaint and adverse reaction reports as necessary.
- Participate in internal and external audits and audit responses.
- Interview, hire, train, evaluate and counsel employees.
- Perform other duties as deemed necessary.
Note: Office-oriented work environment. Must be willing to work weekends and evening hours as necessary. While performing the duties of this job, the employee may be required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 25 pounds.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.
Compensation
Base salary of $70k-$80K, PTO, Benefits and more!
Apply
Please send your updated resume in a word document. Add the month and year for each position as well as how many employees you have managed.
