What we do?
SPECTRAFORCE is an award winning global staffing, IT services and consulting company that specializes in providing top talent and solutions for clients throughout North America and India. We pride ourselves on our partnership with our clients, MSP/VMS providers, and our employees, who have enabled us to continually be ranked as a Top Supplier in the 75+ different clients we support.
Quality Assurance Specialist II
Cambridge, MA, 02139
1 year contract to start
Objectives: (Briefly summarise the overall purpose of the position. Objectives should
be written in 3 – 4 bulleted statements).
• This individual will be responsible for supporting the Commercial Quality Assurance team with day to day operations, including basic lot review activities and archiving for commercial drug substance, drug product and finished goods manufactured by CMOs.
• This individual will support project activities, change controls, investigations, product complaints, and other quality systems as they relate to commercial manufacturing.
• This person will be responsible for supporting a workload from multiple project managers to meet deadlines.
ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).
This position is focused primarily on providing support on routine quality activities.
• Performs documentation review using working knowledge of cGMPs and internal procedures and controls. Drives documentation progression by initiating workflows, following up with multiple stakeholders to complete reviews and collecting and storing all required documents.
• Able to identify and escalate basic technical issues using problem-solving skills, in consultation with management and other cross functional departments.
• Maintain Master Batch Records and other quality related documents as required.
• Provide support for regulatory inspections and GMP audits
• Responsible for engaging with internal and external organizations to drive batch release timelines and escalates when timelies are not met or issues are discovered.
• Supports the team on planning and prioritization of multiple projects and/or the resolution of quality and compliance issues.
• Supports CAPA investigations and works closely with the stakeholder to drive corrective and preventative actions to completion.
• Performs all required trainings on time. Actively participates in group trainings and coaching efforts.
• Supports the evaluation of supplier quality performance and conducts periodic supplier certification assessments as required.
• Compiles quality metrics demonstrating CMO site performance when requested.
• Actively integrates big picture understanding into all interactions. Drives team cooperation and credibility focusing on positive results. Encourages communication, cooperation and win/win solutions.
• Performs additional duties, as assigned.
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).
• Wrist and hand motion (e.g. typing, writing)
• Must be able to work in controlled or clean room environments requiring special gowning
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
BS and 3+ years experience in QA or related compliance experience or MS and 1+ years QA experience.
• Solid understanding of cGMPs as well as applicable regulations and guidances. Demonstrates expertise of department processes, tools and methods.
• Ability to handle multiple tasks concurrently and in a timely fashion.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
• Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
• Must be able to read, write and converse in English.
• Must display eagerness to learn and continuously improve.
• Positive work attitude that supports teamwork and continuous improvement.
• Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
• Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
· Application Submission; we will reach out to you over the phone to discuss important aspects of this job opening and upon agreement your profile will be submitted to the client for review.
· Interviews; Depending on the size of the selection committee, several interviews are scheduled for each candidate. We will coordinate with candidates to set up interviews with our client.
· Job offer; After completion of all the interviews, Hiring Manager confers and evaluates applicants based on the interviews, job experience, skills and talent assessments, and all other relevant information (recommendations, e.g.). A top choice should be identified and agreed on.
· Background checks; After Job offer, background checks would be conducted to review candidates’ criminal record, to verify employment history and eligibility, and to run credit checks. Drug testing may also be warranted, depending on the nature of the job.
· Onboarding; Based on the background checks, first day reporting details would be shared with candidate upon the client ‘instructions.
After completion of all the interviews, Hiring Manager confers and evaluates applicants based on the interviews, job experience, skills and talent assessments, and all other relevant information (recommendations, e.g.). A top choice should be identified and agreed on.
Total Quality Management
Provide Technical Guidance