What are the responsibilities and job description for the Quality Assurance Specialist III position at Precision for Medicine?
Quality Assurance Specialist III
at Precision Medicine Group (View all jobs)
Frederick, MD, USA
Position Summary :
The Quality Assurance Specialist III 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 duties include but are not limited to :
Quality Function :
- 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 (to include closure or resolution in a timely manner) :
- Non-Conformances
- Customer Complaints
- Planned Deviations
- Change Management
- Corrective and Preventive Action (CAPA)
- Supplier Quality Management
- Audit Programs
- Employee Training
- Document & Record Control
- Participating on the Material Review Board
- Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities; serve as lead auditor
- 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
- Independently conduct internal audits, supplier evaluations, and desk audits working with end users to identify performance issues and risk mitigation strategies
- Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews
- Lead 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
- Create and conduct site-wide training for multiple disciplines
Operations Support :
Inspection and release :
Miscellaneous :
Qualifications : Minimum Required :
Other Required :
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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Salary : $75,000 - $110,000
