Position Title: QC Analyst III
Work Location: Portsmouth NH 03801
Assignment Duration: 6 Months
Work Schedule: Shift is either 4/10 hours or 5/8 hours
Work Arrangement: Onsite

Position Summary:
The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies.

Key Responsibilities:
• Acts as an area SME providing technical support within the department and throughout the facility.
• Applies job skills and our organization's policies and procedures to complete a variety of tasks.
• Running test samples for In-Process, Lot Release and Stability studies.
• Support Utility and HVAC monitoring and sampling throughout the facility
• Reviewing assays.
• Training others.
• Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods.
• Projects – such as method transfers, new instruments, method qualifications.
• Use of Microsoft Suites (Word, Excel, PowerPoint).
• Use of Laboratory computer systems.
• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.
• Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Apply Data Integrity principles in all aspects of work, in compliance with our organization's DI policies, guidelines and procedures.
• Perform other duties as assigned.
• Back-up to Supervisor – Independently making quality decisions with input.

Qualification & Experience:
• Bachelor’s degree in Microbiology, Biochemistry or Related Science Fields
• Industry experience, preferably in a cGMP environment - Advanced - 5-10 years
• Agility: Willing to take on new challenges; Demonstrates an ability and desire to learn from experience; Treats errors as a learning opportunity; Supports a culture of process improvement and problem solving; Demonstrates an openness to trying new approaches
• Business Acumen: Seeks to understand the corporate strategy and how his/her business area contributes to the company’s success; Uses knowledge of his/her business area to make accurate and timely decisions; Understands the impact of his/her own actions on his/her business area
• Collaboration: Works as an active member of his/her team; Demonstrates an openness to different perspectives by balancing listening and speaking; Treats all co-workers and customers professionally and with respect
• Customer Focus: Takes action to enhance customer satisfaction within the scope of his/her role; Understands what internal and/or external customers need from him/her to deliver in his/her respective role; Demonstrates an openness to receiving customer feedback
• Driving Results: Consistently delivers goals while monitoring KPIs with supervisor; Ensures quality standards are maintained while delivering results; Plans, prioritizes, and organizes work to deliver on time
• Leadership: Takes responsibility for his/her safety and that of others; Takes responsibility for personal choices and behaviors; Contributes to a positive work environment; Seeks feedback and reflects on his/her development needs in order to continuously improve; Acts as a reliable and dependable member of the team; Act as an example of professionalism to analysts. Mentors other analysts
• Strong ability to speak publicly.
• Strong ability to interpret data both alone and with guidance.
• Perform assigned, complex and/or varied tasks.
• Prioritization and problem solving.
• Comprehend and follow instructions.
• Direct, control and plan tasks/projects.
• Brainstorming
• Strong ability to communicate in both written and verbal format .
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Self-motivated team player
• Completes assignments on-time and accurately
• Displays commitment to quality and performs job functions to the best of his/her ability
• Relate to others in a team setting.
• Maintain positive attitude in a team environment.
• Timeliness in completing assigned tasks.
• Works entire assigned shift, including arriving on time

Working Conditions & Physical Demands (If Applicable):
The normal working environment is: Laboratory
Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.

Quality Responsibility:
Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

Environmental Demands:
The normal working environment is: Laboratory

Physical Demands/Mental Demands:
• Staying alert for duration of shift.
• Being able to make quality decisions as to safety and task at hand.
• Making quick decisions.
• Maintain emotional control under stress.
• Motivating others.
• Maintain professional interactions with co-workers and superiors 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 32.00/hr.