Manufacturing QA Specialist II
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POST DATE 6/6/2020
END DATE 8/5/2020
We are currently searching for a skilled professional to join a well-known client's team as a Manufacturing QA Specialist II in Canton, Massachusetts. The MQA Specialist II role will perform quality assurance activities/decision making associated with cGMP manufacturing, investigations, change control, complaint investigations, and documentation. If you are a career-focused professional, this is the role for you.
* Establish and maintain day-to-day compliance to any requirements for compounded product and the systems supporting compounding
* Identify problems and assist with resolution efforts for quality-related issues associated with the compounding operations
* Support investigation and closure of incidents, change controls, and complaint investigations
* Monitor implementation of appropriate solutions
* Review and approve manufacturing batch records, QC testing, SOPs, and other batch related documentation
* Help with internal, corporate, third party, and federal/state inspections and audits
* Provide reports on measures of local quality system effectiveness
* Participate in QA meetings for Product Manufacturing and Media Fill execution
* Ensure cGMP documentation associated with work activities is complete
* Assist in the disposition of incoming material and final product
* Minimum of 3 years of Quality Assurance experience in a pharmaceutical manufacturing company required
* Experience with aseptic technique, statistical sampling (ANSI Z1.4 Sampling Plan), and Trackwise preferred
* Excellent problem-solving skills
* Demonstrated experience in root cause analysis and six sigma methodology training preferred
* Minimum of Bachelor's Degree in a scientific discipline 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, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/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.