Posted in Other 30+ days ago.
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Type: Full Time
Location: Bedford, Massachusetts
We are currently searching for a skilled professional to join a well-known client's team as QMS Master Control Specialist in Bedford, Massachusetts. The QMS Master Control Specialist role will manage the implementation with the vendor ensuring a successful transfer to new format. Their work will have a direct impact on the organization and also on the larger clinical industry, making this an amazing career opportunity.
* Clean up current documentation which is paper-based, in Word, or PDF and revise the formatting to Master Control format
* Manage day-to-day operations of the project and continually communicate with the vendor (Master Control) throughout process
* Track progress, assess risk, ensure timeline of the project is on track, and keep in communication with upper management
* Assist in the generation of the change control
* Review Installation/Operation Qualification (IOQ) validation packages of the system
* Perform or review the performance Qualification (PQ) validation package of the system
* Verify new system workflow is adapted to existing procedural workflows
* Minimum of 1 year of experience in Project Management required
* Minimum of 4 years of Quality Management industry experience required
* Minimum of 3 years of experience within document control desired
* Demonstrated experience in Biotechnology, Medical Device, or Pharmaceutical
* Experience with Master Control, Electronic Document Management System (EDMS), QMS, or Project Management skills
* Proficient with Microsoft Office Suite and Visio; experience maintaining database systems preferred
* Excellent verbal and written communication skills
* Demonstrated experience in preparing and delivering presentations
* Minimum of Bachelor's Degree in the life sciences required
To be a best-fit your strengths must include
* Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
* Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
* Ability to work independently and with a team. You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
* Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
* Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
* Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.