Operations Support Analyst

Operations Support Analyst

Position Summary:

Under broad guidance from the management team, leads the team, manages and supports overall activities.  Ensures the department priorities and daily production schedules are executed and analyzes opportunities for process improvements.  Builds, develops and promotes communication and a team environment across all shifts.  Champions Performance Excellence initiatives and associated change. 

Essential Duties & Responsibilities:                                                                                                                                                                   Reviews and organizes the planning of the daily, weekly, and monthly production schedules to ensure compliance with department and company goals.  Ascertains product data such as types, quantities and specifications of products and scheduled delivery date.  Actively foster a team focused environment.  Oversee the day to day activities of the team by monitoring work, volume, metrics and schedule.

1. Manages and coordinates the activities of the staff of the specific concentrated area of expertise (however supports all teams).  Ensures proper training and development is provided so there is an adequate, competent staff to accomplish the required tasks.
2. Participate in Dept. Batch Record Review, Master Batch Record & SOP approval, and handle computer transactions for the department as needed – including but not limited to ERP transactions and Metric data collection.
3. Provides guidance to ensure all SOPs, JOB Aids (WI & SEI’s), Batch Records and Logbooks are in compliance with the cGMP regulations and correctly instruct & document the activities performed in the department.
4. Provides technical support in identifying and implementing process improvements, work efficiencies and other cost effective changes.  Identify opportunities for continuous improvement through process observation.  Teaches and encourages others to do the same.
5. Recognize and report when incidents occur.  Support the investigation and writing of the investigation.  Update SOP’s and support CAPA’s.  Train team members on new procedures and practices if requested.
6. Support daily operations in the appropriate capacity which may include running equipment, aiding in cleaning, and/or material movement.
7. Support daily operations in the appropriate capacity which may include running equipment, aiding in cleaning, and/or material movement.
8. Conducts regular reviews of products to ensure quality standards are maintained and GMPs are enforced.  Supports and responds to customer complaints if requested by management.
9. May be assigned a specialty area of focus which will shift essential duties.  Such as ERP, IT, LMS/Training, or another ancillary function to ensure the business is operating optimally.
10. Creates awareness of the importance of a safety and quality focused working environment through coaching, training, on the floor presence/awareness, cGMP compliance, safety guidelines and SOPs. 
11. Follows safety policies and procedures. Performs other duties as assigned or required.

Conducts regular reviews of products to ensure quality standards are maintained and GMPs are enforced.  Supports and responds to customer complaints if requested by management.

Physical Requirements:

• Lift/move up to 40 lbs and occasionally up to 45 lbs.  Able to work safely with heavy equipment.  Regularly stand, walk, sit, use hands and fingers, feel objects, tools, controls, reach with hand(s) and arm(s), talk, hear, and good vision.
• Individual may be required to wear Personal Protection Equipment.
• Not allergic to chemicals or bio substances found in laboratory or production facilities.

Position Requirements:

Education Required:

• High school diploma or GED required.College degree preferred.
• Experience in a pharmaceutical, chemical, biochemical, or food manufacturing environment.
• 3 – 5 years of previous experience in a related field.