Quality Assurance Specialist III Medical Device, Precision Medicine Group, Frederick, MD
Precision Medicine Group -
N/A
Frederick, MD,
US
N/A
Quality Assurance Specialist III Medical Device
Date Posted: 2024-04-23
Job description
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.
Position Summary:
The Quality Assurance Specialist III -Medical Device will provide advanced-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment. Activities include but are not limited to, product label control, internal auditing, and quality inspection & release of raw materials, in-process materials, finished products, and critical components. In addition, this position is responsible for providing backup for the document and record control system. Extended work hours may be necessary in order to meet business demands.
Essential functions of the job include but are not limited to:
Assist in maintaining established company wide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events including:
Non-Conformances
Customer Complaints
Planned Deviations
Change Management
Corrective and Preventive Action (CAPA)
Audit Programs
Participating on the Material Review Board
Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities
Analyze data resulting from monthly metrics and reporting tools for all aspects of quality systems, connecting data and forming conclusions regarding the compliance health of PFM, to include presentation of metric performance to management representatives and proposing durable solutions
Respond to supplier look-back notifications. Investigate and determine disposition of material
Monitor equipment calibration program to ensure timely and accurate completion of maintenance
Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews
Support departmental projects aimed operational process understanding efforts (process mapping)
Act as a change-agent and QA lead during continuous improvement and global harmonization efforts
Provide guidance to junior level QA specialists
Client-facing activities as assigned by department head such as leading client visits/audits and representing QA during project kick-off meetings and customer complaints for the CDx projects
Create and conduct site-wide training for multiple disciplines
Support validation activities, including review and approve validation protocols, reports, and final package documentation
Support the maintenance and review of DHF and actively participate in all Design Control activities pertaining to the CDx projects
Assist in the QA review and acceptance of customer specifications to conform to contractual requirements
Generate and maintain label formats for manufactured and resale products
Generate and maintain Certificates of Analysis for finished products and products for resale
Inspect and approve all product labels generated by Operations
Provide support to other departments regarding requests, release status, regulatory requirements and other tasks as requested
Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services
Maintain filing and storage systems for document control, training and batch records for raw and finished product
Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability
Inspect and release incoming raw material, critical components, packaging and labeling in accordance with individual specifications and standard operating procedures
Perform batch record review and release for finished product, raw materials, intermediate solutions, and services
Conduct product inspections, review repack records
Miscellaneous:
May participate actively on the safety committee, as needed
Assist in training new and existing personnel
Participate in regulatory, notified body, and customer audits as needed
Provide back-up coverage for other Quality Specialists
Carry out other duties/projects as assigned
Qualifications:
Minimum Required:
Bachelor's Degree or equivalent combination of education and experience
4 years of related experience in a life science, regulated environment
In-depth knowledge of ISO 13485 and 21 CFR Part 820 standards
Other Required:
Experience working in a Quality Department/Life Sciences-Regulated environment, including experience independently conducting internal audits, document review from a technical and quality perspective, batch release, incoming inspection
Knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements
Ability to meet deadlines and perform administrative functions
Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
Ability to organize tasks, work independently and adapt to changing priorities
Ability to function independently within a minimally supervised environment with exceptional attention to detail required
Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
Must be able to read, write, speak, fluently and comprehend the English language
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$75,000-$110,000 USD
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. 2020 Precision Medicine Group, LLC
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