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location: Milford, Massachusetts
job type: Contract
salary: $28.90 - 34.00 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
As part of the Quality Assurance team, the Quality Associate II is responsible for identifying and assessing regulatory and quality risks, ensuring that all manufacturing and related activities and processes are performed according to company's rigorous quality standards and in strict compliance with regulatory agency rules and guidelines. The Quality Associate II is "on the floor" as needed and maintains a high level of expertise in current regulatory requirements, serving as a plant resource for compliance to these requirements.
- Act as leader for electronic quality systems including generating data and reports in order to provide actionable data, query building, and data presentation.
- Work closely with facility and manufacturing departments to support (review/approve) Manufacturing batch records, utility and equipment deviations, change controls, validation studies, work orders and calibration, etc. against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on Good Documentation Practices, regulatory requirements and internal guidelines.
- Improve current practice to reduce cycle time using real-time review of batch records within the core manufacturing suite.
- Review pertinent documents, records and reports such as Manufacturing Batch Records, lab test results, etc. against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on Good Documentation Practices, regulatory requirements and internal guidelines.
- Completing raw material and batch package release for drug substance and product, including communication of timelines and actions with other sites.
- Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant and other regulatory requirements.
- Determine the logic, adequacy and effectiveness of Quality processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance. Participate in continuous improvement initiatives with the department and site wide.
- May provide training to employees on relevant Quality and compliance area(s).
- Participate in external assessments and audits by evaluating and solving product/process problems by providing technical and analytical skills.
- Support process with timely closure of observations/audit items.
- Other duties, tasks or projects as assigned.
qualifications: Education & Qualifications
- BS in Mechanical/Chemical Engineering ore related science field preferable
- 3 - 5 years of experience in the Quality function within a biotech or pharmaceutical company or other similarly regulated industry.
- Experience in equipment calibration and validation would be a plus.
- Expertise in electronic quality systems including advanced data mining/reporting and query building. Additional computer experience should include utilizing industry standard quality and MS Office systems. Outlook, Word and Advanced Excel skills are a plus.
- Strong knowledge of FDA CGMP regulatory requirements as they apply in a biologics manufacturing environment. Change control experience is a plus.
- Experience with Project Management as Project Leader and/or team participant.
- Strong interpersonal skills including the ability to effectively communicate (verbally and in writing) with all levels of personnel in the organization. A demonstrated team player with resourceful problem-solving abilities and exceptional attention to detail.
- Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
- Good communication skills - verbally and written
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.