Quality Assurance Specialist careers in Actalent Rockville, MD

Website Actalent

This Jobsfunter Listing is about Actalent in Rockville, MD 2022

About the job

  • Description:* Position Summary: The Quality Assurance (QA) Specialist is accountable for activities that support regulatory and cGMP compliance programs and initiatives; duties of this position are to be completed under the supervision of the Quality Assurance Supervisor.

The QA specialist possesses keen attention to detail; must be able to spot when processes don’t comply with guidance and provide alternative suggestions.

This position possesses sharp analytical skills; gathering and interpret data, spotting trends and noticing outliers.

The incumbent actively supports and complies with all corporate and departmental policies and procedures. All functions are to be completed in a timely manner with acceptable quality. Duties and Responsibilities:

  • Understand the goals and objectives of the organization; communicates, develops, motivates, and assists with staff training, as necessary, to help achieve the company’s Quality goals.
  • Assists with development of standard operating procedures applicable to Quality System Regulations.
  • Assists with the administration of corrective and preventive action in accordance with standard operating procedures.
  • Advises internal customers to ensure regulatory and ISO compliance with product development goals according to company SOPs.
  • Functions as a lead auditor in assisting with both internal audits and vendor audits to ensure compliance to documented procedures. Supports the department with resolution and monitoring of any identified action items.
  • Assists with the issuance, control, receipt, and maintenance of lab books.
  • Assists with the issuance, control, receipt, and review of batch records.
  • Assists with training staff in accordance with quality-related policies and procedures as requested.
  • Performs other ancillary duties as assigned. Position Summary: The Quality Assurance (QA) Specialist is accountable for activities that support regulatory and cGMP compliance programs and initiatives; duties of this position are to be completed under the supervision of the Quality Assurance Supervisor.

The QA specialist possesses keen attention to detail; must be able to spot when processes don’t comply with guidance and provide alternative suggestions.

This position possesses sharp analytical skills; gathering and interpret data, spotting trends and noticing outliers.

The incumbent actively supports and complies with all corporate and departmental policies and procedures. All functions are to be completed in a timely manner with acceptable quality. Duties and Responsibilities:

  • Understand the goals and objectives of the organization; communicates, develops, motivates, and assists with staff training, as necessary, to help achieve the company’s Quality goals.
  • Assists with development of standard operating procedures applicable to Quality System Regulations.
  • Assists with the administration of corrective and preventive action in accordance with standard operating procedures.
  • Advises internal customers to ensure regulatory and ISO compliance with product development goals according to company SOPs.
  • Functions as a lead auditor in assisting with both internal audits and vendor audits to ensure compliance to documented procedures. Supports the department with resolution and monitoring of any identified action items.
  • Assists with the issuance, control, receipt, and maintenance of lab books.
  • Assists with the issuance, control, receipt, and review of batch records.
  • Assists with training staff in accordance with quality-related policies and procedures as requested.
  • Performs other ancillary duties as assigned.
  • Skills:* Quality assurance, GMP, Compliance, Audit, ISO, Quality System
  • Top Skills Details:* Quality assurance,GMP,Compliance,Audit,ISO,Quality System
  • Additional Skills & Qualifications:* Minimum Qualifications and Requirements:
  • Bachelor Level Degree in a scientific discipline.
  • Extensive knowledge of applicable US FDA and EU regulations and the ability to stay current on regulations.
  • Extensive knowledge of ISO standards.
  • Minimum of two (2) years’ recent experience in publishing/Regulatory Operations in the biotechnology or pharmaceutical industries
  • Ability to follow written procedures.
  • Ability to work independently or in a team environment is essential.
  • Ability to perform trend analysis on data
  • Proven ability to handle multiple projects simultaneously
  • Ability to effectively write standard operating procedures
  • Self-starter, motivated and takes initiative; strong interpersonal and problem-solving skills; able to work collaboratively with all levels of staff to resolve problems and external partners to maximize performance, creativity, problem solving and results.
  • Seek, learn, and apply new skills/knowledge to perform job responsibilities.
  • Attentive to detail with a high level of accuracy; exercise sound judgment.
  • Resourceful, diplomatic and professional; deliver outstanding customer; a can-do attitude and work style that supports teamwork, collaboration and positive relationships.
  • Adaptable; be able to shift priorities and focus as departmental and/or business demands change.
  • Strong analytical skills and organized; completes tasks ahead of schedule.
  • Excellent written and verbal communication skills, including excellent listening skills and presentation skills to communicate clearly, concisely and effectively.
  • Position-relevant computer experience including Microsoft Office.
  • Follow all company safety practices, Standard Operating Procedures (SOP’s) and policies. Preferred Qualifications:
  • Experience with ISO, GXP or other Quality Systems.
  • Experience with electronic document systems.
  • Experience Level:* intermediate level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Company: Actalent

Vacancy Type: Contract · Entry level 

Job Location: Rockville, MD

Application Deadline: N/A

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