Quality Assurance Compliance Specialist III - Worcester, United States - Actalent

Description

12 month renewable contract

Hybrid Schedule, expected to be on site 3 days per weeks

Description:

Monitors compliance with all policies and procedures in addition to all federal/state/local/global and pharmaceutical laws and regulations.

Responsible for implementing and maintaining the effectiveness of the Quality System.

Ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.

Ensure investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Perform product impact analyses for plant events and places product on QA hold where appropriate.

Supports investigations and provides metric collection for timely resolutions to exceptions events, out of trend events, facilities and document Risk Management activities (eg FMEA).

Develops QA training programs for various processes and may provide training to departmental personnel.

Provide support in defining statistical design and analysis for process development, technology transfer, analytical development, process validation and re-qualifications, manufacturing, chemistry and microbiology laboratories, incoming QA, investigations, CAPA's, compliance, complaints process.

Manage QA lists, spreadsheets and databases as required by site operations.

Evaluates, analyzes and trends quality indicators.

Prepares reports of quality operations, productivity as well as monthly quality metrics.

Prepares QA presentations suitable for management and external customers.

Participates in Improvement initiatives and assures quality compliance.

Support change control activities

Additional Skills & Qualifications:

Bachelors degree, preferably in Science or Engineering or equivalent related work experience.

5 to 10 years experience

Knowledge of applicable regulations and standards affecting Pharmaceutical Products (eg CFR 210/211, cGMP, DEA) and CGMP environments.

Strong analytical skills, ability to analyze data, trends and draw conclusions.

Computer skills, especially with Excel, PowerPoint and Visio programs to create automated metrics and visuals.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are Embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email (see below) for other accommodation options.