Senior GMP Compliance Specialist
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POST DATE 5/5/2020
END DATE 7/4/2020
Morris Plains, NJ
We are currently searching for a skilled professional to join a well-known client's team as a Senior GMP Compliance Specialist in Morris Plains, New Jersey. The Senior GMP Compliance Specialist role will ensure a continuous and sustainable state GMP compliance, through internal audit, monitoring, and oversight of self-inspection programs. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
* Lead Internal Audits as outlined in the yearly audit plan
* Escalate compliance concerns
* Track and trend Self Inspection and Internal Audit observations/responses through to a successful closure
* Prepare and provide on-site support to sites for regulatory inspections and third-party audits
* Share best practices and communication of lessons learned across the organization
* Develop tools for implementation of an effective self-inspection program and train across organizations
* Perform effectiveness checks of self-inspection programs and compliance investigations
* Review complex investigation reports of non-compliances in GMP areas
* Conduct and support pre-approval/pre-submission project reviews, mock inspections, and inspection readiness assessments
* Ensure Good Documentation Practices (ALCOA) are followed
* Create, review, apply, and/or approve appropriate policies, directives, and procedures in alignment with relevant governmental regulations and guidelines
* Participate during regulatory agency inspections, as needed
* Assist in submission data verification reviews, as applicable
* Minimum of 6 years of experience in the biotechnology, pharmaceutical, or (GxP) industry required
* Excellent written and verbal communication skills required, including responsible business communication
* Knowledge of relevant GMP regulations and guidance; including, but not limited to, 21 CFR, ICH, EU GDP/GMP, and PIC/S
* Technical knowledge of Manufacturing, Facilities, Equipment, and/or Laboratory procedures/processes in the Biologics space preferred
* Strong attention to detail, organizational skills, and ability to handle multiple tasks in a timeline-driven environment
* Proficient with all MS Office applications
* Experience in GMP Audits required
* Minimum of Bachelor's Degree in a Technical/Science related field (Biochemistry, Engineering, Chemistry, Biology, etc.) 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.