Quality Control Specialist

2 weeks ago


Social Circle, Georgia, United States BioSpace, Inc. Full time
About the Role

We are seeking a highly skilled Quality Control Analyst II to join our team. As a Quality Control Analyst II, you will be responsible for providing quality support and oversight through direct staff supervision or process/area responsibilities. You will identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and the company quality practices.

Key Responsibilities
  • Lead ongoing, daily departmental operations.
  • May include the guidance of assigned personnel in achieving defined quality goals. Interview/hire, evaluate, train, and develop direct reports.
  • Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
  • Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
  • Determine the logic, adequacy and effectiveness of systems and related requirements.
  • Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
  • Write, review, analyze, and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements.
  • Navigate, answer alerts and review Batch Records in EBM.
  • Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns.
  • Support external audits.
  • Help with audits of multiple reports (Protocols, Qualifications, Regulatory Submissions).
  • Be a Subject Matter Expert (SME) and provide training to local employees on relevant area(s).
  • Identify when proper practices/procedures are not performed. Follow SOPs and identify processes and results.
  • Implement changes and corrections. Escalate accordingly. Ensure communication of issues.
  • Ensure communications between personnel, groups, and between departments.
  • Coordinate activities and schedules staff.
Requirements
  • Requires bachelor's degree in science, engineering or other related technical field. 3+ years of related experience.
  • Proficient in wet and instrumental methods of analyses.
  • Advanced laboratory skills and basic knowledge of statistical method.
  • Must demonstrate effectiveness in ability to train others.
  • Knowledge of most laboratory equipment including autoclaves, incubators and analytical equipment.
  • Must be proficient in multiple mathematical operations and calculations and be able to work with both the metric and US standards of measurements.
  • Will read and follow detailed written instructions and have good verbal/written communication skills.
  • Knowledge of basic chemical and biological safety procedures.
  • Knowledge of Microsoft Word, Excel and PowerPoint.
About Us

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

What We Offer

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.



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