Quality Assurance Specialist

Quality Assurance Specialist

Job Description:

We are seeking a dedicated Quality Assurance Specialist to join our team in Ayer, MA. In this pivotal role, you will provide comprehensive QA support to our Devens site, ensuring compliance with regulatory expectations and internal standards. Your primary responsibilities will include performing quality reviews and approving investigations and corrective action plans. You will make critical decisions regarding non-conformance and leverage your deep understanding of quality systems to maintain high product quality standards. This position involves reviewing and approving quality control, validation, and automation-related documents, as well as standard operating procedures. Additionally, you will be responsible for the review and approval of validation documentation, including risk assessments, protocols, test scripts, and summary reports. You will also evaluate change proposals and ensure that all deliverables align with regulatory guidelines. The role requires strong coaching abilities to guide various departments through investigations, CAPAs, and risk assessments, while also managing multiple projects in a remote work environment. Your analytical skills will be essential for interpreting complex data and making sound independent decisions.

IT Languages:

• English
• SAP
• LIMS
• TrackWise
• Veeva Vault

As a Quality Assurance Specialist, you will perform a range of critical tasks that ensure product quality and regulatory compliance.:

Provide QA support through quality reviews and approvals of investigations and corrective actions;; Make decisions on non-conformance based on quality system regulations;; Review and approve quality-related documents and standard operating procedures;; Evaluate validation documentation including risk assessments and protocols;; Assess change proposals to ensure compliance with internal and external guidelines;; Coach different departments on investigations, CAPAs, and risk assessments;; Manage multiple competing deliverables effectively in a remote environment;; Analyze complex data to make informed decisions independently

Spoken Languages:

• English

Skillset:

• Quality assurance
• Regulatory compliance
• Technical writing
• Validation procedures
• Change management

Soft Skills:

• Strong communication skills
• Attention to detail
• Problem-solving abilities
• Ability to work independently
• Coaching and mentoring skills

Qualifications:

• Bachelor's degree in biological science, engineering, biochemistry, or related field
• 8 years of experience in GMP, GCP, or GXP environments focused on product quality
• Active member of ASQ or ISPE preferred
• Experience in QC equipment qualification and project management
• Knowledge of biotech, bulk drug substance or finished product manufacturing
• Familiarity with US and EU cGMP regulations and GAMP 5
• Experience with electronic systems such as SAP, LIMS, TrackWise, Veeva Vault

Years of Experience:

8

Location:

Ayer, MA, United States

Job Benefits:

• Health benefits
• Dental insurance
• Vision insurance
• 401K plan with matching
• Commuter benefits
• Referral bonus program

Working Conditions:

Full Time

Employment Type:

Temporary Contract

Company Culture:

• We foster a culture of human connection, emphasizing the importance of teamwork, collaboration, and the joy of bringing people together. Our environment encourages professional growth and personal development, ensuring that every employee can reach their highest potential.

Opportunities For Advancement:

• Professional development programs, Leadership training, Mentorship opportunities

Visa Sponsorship:

Not Available