Manufacturing Quality Compliance Specialist

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Manufacturing Quality Compliance Specialist
Location: Portsmouth, NH 03801
Duration: 5 Months
Job Type: Temporary Assignment
Work Type: Onsite

Summary

• Lead gap assessments of local Quality Management System procedures against Group Quality Procedures and Corporate Standards
• Coordinate updates to local SOPs, work instructions, and controlled documents
• Track implementation and drive completion to defined timelines
• Partner with process owners and SMEs to establish and implement compliant solutions
• Support Change Control, CAPA, Deviations, and Quality Risk Management activities
• Support internal audits and regulatory inspections
• Monitor compliance metrics and prepare management reports through trending and visual KPI management
• Develop and provide training and guidance on new or revised quality procedures
• Drive continuous improvement and harmonization of Quality System processes
• Incorporate rapid changes in priorities into QA projects and schedules, communicating those changes positively to staff
• Support other functional areas when needed and assume additional responsibilities during projects or personnel transitions
• Suggest new ideas or recommendations for identified compliance concerns
• Communicate status, needs, forecasts, risks, and timelines effectively to management
• Collaborate with cross-functional team members while managing normal stress to meet project deadlines
• Present information and ideas clearly, verbally and in writing, to stakeholders
• Respond to stakeholder requests in an effective and professional manner
• Proactively identify gaps or issues and lead efforts to implement workflow improvements
• Take personal accountability for outcomes and ensure clear, direct two-way communication within the team and with other organizations

• Bachelor's Degree or Master's degree, or equivalent experience, in Life Sciences, Business, Engineering, or a related field (Scientific field preferred)
• 3-5+ years in a GMP environment, with 1 to 3 years in Quality Assurance or a similar discipline; biotechnology manufacturing background preferred
• Knowledge of cGMP and applicable regulations
• Project management experience, including presentation, customer liaison, and meeting facilitation
• Experience with Trackwise, SAP, and document management systems is highly desired.
• Strong planning, organizing, and controlling skills, with sound decision-making across a broad scope of factors
• Ability to manage multiple priorities, meet tight timelines, and work well under pressure
• Strong analytical and critical thinking skills
• Detail-oriented, self-motivated, and adaptable to changing business priorities
• Excellent written and verbal communication skills, with a willingness to listen and collaborate effectively individually and within teams
• Professional, customer-focused attitude with consistent safety awareness
• Skilled at interpreting stakeholder inquiries and addressing difficult situations professionally

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.