QA Compliance Specialist

Job Title: QA Compliance Specialist
Location: Worcester, Massachusetts, 01604
Duration: 12 Months (Potential extension)
Pay rate starts: $45/hr (Negotiable)

Description:
* Monitors compliance with all Client 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 (e.g. 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

Requirements:
* 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 (e.g. 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.

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.