Regulatory Affairs Associate
Primary function of the Regulatory Affairs Associate is to serve as a regulatory liaison to clients and internal functional departments.
Assists in the implementation, execution and maintenance of quality systems to ensure Ash Stevens complies with regulatory requirements as propagated by the United States Food and Drug Administration (FDA) and similar international regulatory bodies. Principal assignments related to compliance will include writing documents, review of records and data, review and implementation of new or revised documentation to ensure that ASI drug regulatory requirements are met.
Participate in outside meetings, forums, etc. to ensure the latest thinking is applied to Regulatory and Chemistry, Manufacturing and Controls (CMC) strategies.
As talents and experience dictate, the Associate will interact with auditors from regulatory bodies and clients.
KEY DUTIES AND RESPONSIBILITIES:
- Document Preparation and Review - 60%
Assist in the writing, preparation and/or review of documents to ensure compliance with FDA requirements, quality agreements and regulations.
Accurately authors and assembles documentation for client regulatory submissions.
Reviews proposed product changes for impact on regulatory status of the product and provides regulatory guidance and support for development and production activities.
Partner with internal and external customers to assemble and review data in support of annual regulatory filings and in support of the preparation of the CMC portions of INDs, DMFs and NDAs, amendments and supplements.
Support maintenance of regulatory reporting schedules.
Assist in document record maintenance and destruction in accordance with SOPs.
Provide other regulatory and quality assurance support as needed to colleagues within ASI.
- Reports - 20%
The Associate will assist in the development and preparation of regulatory reports for the file or for submission to regulatory bodies. In addition, the Associate will participate in the preparation or review of associated documentation, such as, Cleaning Validation Reports and Process Performance Qualification Protocols and Reports.
- Continuous Learning - 10%
Maintain current knowledge of FDA and other pertinent Health Authority regulations for effective regulatory submissions. Remain current on FDA updates including new policies and guidances.
- Meetings with customers and investigators - 10%
Participate in discussions with customers and investigators.
Education and Experience:
- Minimum Bachelor’s degree in science, chemistry or chemical engineering degree is preferred.
- 2-4 years’ experience in regulatory affairs or related field in pharmaceutical manufacturing preferred
- Experience with the application of Design Of Experiment (DOE) and Quality by Design (QbD) a plus.
- Knowledge of GMP requirements (21 CFR Part 211 and/or ICH Q7a)
- Knowledge of Drug Regulatory requirements, specifically as relates to preparation of
- CMCs, DMFs or CTDs.
This position is intended as a mid-level position. As the individual develops an understanding of internal and external requirements, opportunities for growth are available.
Essential Skills and Abilities
- The successful candidate should have good organizational and planning skills
- The successful candidate should have strong written, verbal and interpersonal communication skills.
- The successful candidate should possess effective skills for developing, performing, evaluating, troubleshooting within a scientific/technical discipline.
- RAC and/or related professional certifications or willingness to obtain such certification is preferred.
Physical Requirements/Work Environment
- Must be able to lift/push/pull up to 30 pounds occasionally
- Ability to work on a computer the majority of the day
- Potential limited exposure to hazardous chemicals
- Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
Applicants must be authorized to work in the US for any employer without visa sponsorship.
Please send resumes to:
Ash Stevens Inc.
18655 Krause St.
Riverview, MI 48193
Inventory Control Clerk
Reports to: director, finance
FLSA Status: NON-exempt
Supervises Others: No
The Inventory Control Clerk is responsible to maintain inventory in several key areas (including production/plant and also maintenance and repair parts) and development and maintenance of a tool crib. The incumbent will also function as support for shipping and receiving.
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
Shall adhere to all safety, health and environmental procedures, policies and practices.
KEY DUTIES AND RESPONSIBILITIES:
Inventory Management- Plant:
- Maintain inventory levels of most commonly used materials, i.e. solvents, tubing, bottles, etc.
- Enter order requests to restock (with input from Purchasing Manager).
- Review listing of expired materials and ensure their transfer physically and in the system to the proper hold locations, along with updated labelling.
- Ensure that materials in quarantine, hold, or approved are in their designated areas at all times. Approval stickers will be applied when provided by QA and material moved to approved location.
- Ensure acid/base, etc. designations are understood and are stored in proper locations.
- Develop and deploy cycle count system for both GMP inventory and maintenance parts.
- Responsible for both Epicor inventory and paper dispensing records. When material is completely used up, ensure the system correctly reflects no inventory remaining and the paper dispensing record is closed with the variance calculations completely correctly and submitted to QA.
Inventory Management- Maintenance:
- Develop and deploy inventory system for maintenance parts (spare parts for critical plant equipment, general spare parts, and general supplies).
- Maintain tool crib for special tools, one-of-a-kind pieces of equipment, ladders, extension cords, etc. Keep tools is good working order; inspect for safety and functionality before issuing and once again upon return.
- Maintain proper inventory levels for maintenance parts to ensure operational requirements are met. Put in order requests to restock (with input from Facilities Manager).
- Work with Facilities Manager to determine old/obsolete parts and items no longer needed.
- Work with outside vendor (Bentley) for removal of waste from site.
- Prepare inventory of waste and sign manifests/paperwork as required when removed from site.
Shipping and Receiving:
- Be the trained/certified backup for Shipping and Receiving.
- Shipping- knowledge of FedEx website, types of shipments (including documents as well as large international shipments with specific shipping requirements). Knowledge of shipping requirements for hazardous materials and shipping with dry ice.
- Receiving- must understand receiving requirements under GMP, storage, and labelling conditions. Notify employees as appropriate of shipments received.
- Maintain various databases, as necessary, to support the plant.
- Other duties as assigned, to meet the needs of the customer.
- Minimum high school diploma or equivalent.
- One (1) year minimum experience in an industrial environment (chemical preferred).
- Two (2) year’s verifiable experience driving an industrial power truck.
- Excellent organizational and record keeping skills.
- Strong written, verbal, and interpersonal communication skills.
- Proficiency in computer applications (Microsoft Office, ERP systems, etc.).
- Knowledge of regulations related to shipment of dangerous goods.
Physical demands and work environment:
- The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Physical demands:
- Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
- Long periods of sitting and walking may also be expected in this position.
- This position may require long periods of sitting, typing, computer entry or looking at a computer.
- Potential limited exposure to hazardous chemicals.
- Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.