Quality Assurance Specialist II
6 days ago
We are currently searching for a skilled professional to join a well-known client's team as a Quality Assurance Specialist II in Los Angeles, California. This onsite role will support Quality Management Systems, donor chart review, tissue release, complaints, and other process improvements. Apply today to talk with one of our recruiters and learn more about this amazing career opportunity.
RESPONSIBILITIES
- Review sperm donor charts for completeness of all required testing/documents prior to release of tissue
- Redact and/or review egg donor Summary of Records (SOR) packets for completeness and/or accuracy
- Report and track errors discovered during the sperm donor chart or egg donor SOR packet review process
- Evaluate vial and egg device status change forms for completeness/signs
- Initiate and update SOR reports as part of the tissue release process
- Create addendums and tables, maintain report folders, and review documents for completeness (proper data entry, scanning, naming, saving, archiving of reports, etc.)
- Scan and file applicable documents in sperm donor charts as applicable
- Assist with Deviation, Complaint, Nonconformance, and CAPA team activities
- Perform data entry and basic statistical analysis by creating graphs/reports for various quality activities
- Help with chart audits for reproductive tissue services
- Support and implement Process Improvement activities
- Write reports/correspondences, respond to common inquiries/complaints from clients and regulatory agencies, and follow up/answer questions from coworkers and management
- Collaborate with appropriate staff, revise procedures, and format documents/forms using Word, Excel, and Acrobat
- Provide coverage to complete documentation required for international orders, as necessary
EXPERIENCE
- Minimum of 2 years of healthcare, clinical laboratory, or tissue banking experience and/or training required
- Knowledge of FDA HCT/P regulations (21CFR1271) and quality certification preferred
- Excellent spoken and written English ability to communicate effectively/professionally with clients and external contacts
- Ability to read and interpret documents (donor eligibility/suitability forms, procedure manuals, etc.)
- Computational skills required to support essential duties/responsibilities (fractions, percentages, ratios, and proportions)
- Experience with statistical applications preferred
- Ability to analyze data, carry out instructions furnished in written/oral form, and solve problems involving several concrete variables in standardized situations
- Strong ability to plan, organize, and complete assignments logically and independently
- Proficient in Microsoft Office, SharePoint, Adobe Acrobat, and MasterControl
- Ability to produce accurate work, follow procedures, meet deadlines, and manage multiple priorities
- Good problem-solving skills
- Ability to work independently with minimal supervision
- Excellent customer service, interpersonal, and management skills
- Strong attention to detail and ability to maintain confidentiality
EDUCATION
- Minimum of Bachelor's Degree in Biological Science or a closely related area of study 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 a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions
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.
Equal Employment Opportunity
It is Advanced Clinical'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.
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