: Quality Assurance Senior Associate (JP8367)
Woburn Massachusetts 01801
: 12 months with likely extensions
Job posting date
Note: Onsite Essential
Option of Two shifts
: first shift (7am-3pm) OR second shift (3pm-11pm). Please indicate on top of resume which shift candidate is open to.
3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Top Must have Skill Sets:
- Bachelors, 4+ years/ Associates 6+ years: Quality, Manufacturing, Validation, Process Development or Process Engineering experience (PHARMA OR BIOTECH)
- The Senior Associate Quality Assurance will be accountable for Quality On-the-Floor in support of Manufacturing activities.
- This position provides the opportunity to work directly with Manufacturing staff during operations to facilitate real-time decision-making regarding quality requirements and deviations.
- This is a unique opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff.
- The client’s Quality Assurance On-the-Floor provides mentoring, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems.
- Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
Bachelor’s degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience, OR
- Associate’s degree and 6 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience, OR
- High school diploma / GED and 8 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience.
- Previous QA oversight of manufacturing, analytical and engineering activities.
- Responsible for providing Quality oversight to ensure that operations for licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
- Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
- Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to deviations, CAPAs, and validations.
- Supports Continual Improvement initiatives, programs and projects.
- Ensures that changes that could potentially impact product quality are assessed according to procedures.
- Ensures that deviations from established procedures are investigated and documented per procedures.
- Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
- Alerts senior management of quality, compliance, supply and safety risks.
- Represents the quality unit during audits and inspections as needed.
- Supports internal/external audits and inspections as part of the audit/inspection management team as needed.
- Completes required assigned training to permit execution of required tasks.
Employee Value Proposition:
- Organizational skills, including ability to follow assignments through to completion.
- Skills in leading, influencing and negotiating.
- Knowledge in area of expertise
- Collaborate and coordinate with higher level outside resources.
- Knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Ability to interact with regulatory agencies.
- Word processing, presentation, database and spreadsheet application skills
- Communication (both written and oral), facilitation and presentation skills
- Skill in working independently and to effectively interact with various levels.
- Basic data trending and evaluation
- Ability to evaluate compliance issues.
Ability to be a part of the cleint’s Mission and Values
Jumpy job history, lack of: Quality, Manufacturing, Validation, Process Development or Process Engineering experience
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.