Job Description
Quality Specialist II, PMS and Stability
Position Summary:
Quality Specialist II, Post Market Surveillance (PMS) and Stability will provide support in preparation of data analysis, reporting, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews and review and closure of certain categories of complaints. It requires regulatory assessment capability along with MDR/Vigilance reporting. The Post Market Surveillance Specialist may also review and monitor data and document quality, as requested by the manager.
Key Responsibilities:
Product Stability:
• Coordinates and performs various stability testing in accordance with stability protocols.
• Ensures stability samples are available and placed in stability chambers at the appropriate time frames to meet the requirements of the stability protocol.
• Ensures stability samples are pulled at the appropriate time frames to meet requirements of the stability protocol.
• Analyzes stability test data utilizing the department stability software program.
• Assists Risk and PMS manager with summarizing stability data for submission into the final stability report.
• Ensures testing and data analysis is completed in a timely manner to meet business and regulatory deadlines.
• Identifies Out of Specification results and notifies manager in a timely manner.
• Notifies manager immediately when adverse stability data trends are identified.
• Ensures stability chambers are maintained and calibrated according to internal and external quality and regulatory requirements.
Minimum Requirements:
• Bachelors degree in Biological Sciences or a related field.
• Six years of experience in a Quality regulated environment.
• Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications.
Preferred Qualifications:
• Background in diagnostics.
Knowledge of:
• Detailed knowledge of ISO 13485 and GMP regulations which govern a medical device and diagnostics manufacturing. Knowledge of complaint handling requirements.
• Tracking and trending tools and reporting techniques.
Ability to:
• Good procedural writing skills a plus.
• Exercise independent discretion and judgment in execution of duties.
• Plan and organize oneself in a consistent manner.
• Be a self-starter with the ability to positively motivate others in a cooperative fashion.
• Establish and maintain effective working relationships with other staff members.
• Effectively communicate both orally and in writing to management, customers and regulatory personnel.
• Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry.
About Advantage Resourcing
Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.