EHS and CDS Coordinator I - Quality Assurance
Position Summary...
ARL Bio Pharma is the leading pharmaceutical quality, safety and sterility testing laboratory in the nation with an exceptional reputation for providing quality science and client service. The Controlled Dangerous Substance Coordinator (CDS) I is an entry-level position working under direct supervision, performing a variety of duties to ensure the company’s compliance with federal, state, and industry standards and regulations. Following department Standards and Operating Procedures (SOPs) the position will perform increasingly complex tasks to verify compliance and chemical safety concerns in ARL Bio Pharma. Employing standard and innovative techniques, the CDS Coordinator I will manage physical and digital databases and other administrative filing systems to ensure simplified identification, improved accessibility, and effective organization. This position will gain valuable experience, building relationships with internal and external agencies and stakeholders, and assisting them with routine questions and concerns, escalating as appropriate. Participating in departmental discussions to assess technical and operational issues. Collaborate with supervisors and colleagues.
Because of the safety-sensitive nature of this work and both DEA and FDA regulations, we do not allow medical marijuana cards, and we do random drug testing on all our employees.
- 100% Company-paid Medical, Dental and Vision Insurance
- Paid Holidays and Paid Time Off
- Company matching 401K Retirement Plan
- Free lunch daily
- Fantastic working environment and amazing people
Work Schedule: Generally, 8:00 - 5:00 Monday through Friday. Days and Hours of Work vary by assigned tasks depending on business needs. Some Flexibility is required as occasional extensions outside the normal schedule and weekends may be necessary to meet business needs.
Job Duties...
- Assist the Quality Assurance (QA), Environmental Health & Safety (EHS), and Controlled Dangerous Substances (CDS) Managers with department projects to ensure compliance with all federal, state, industry, and company regulations.
- Assist with reconciling controlled substances records, verifying a large inventory of chemicals with various classifications, including but not limited to Hazardous, Flammable, Toxic, Corrosive, Oxidizing, and Hazardous, within ARL's own systems.
- Maintain accurate and efficient physical and electronic record systems employing techniques such as accurate labeling to simplify identification and improve accessibility.
- Perform daily and cyclical administrative support tasks, including scanning documents into various systems.
- Assist in various investigations such as diversions, near-miss, compliance concerns, and other appropriate tasks as assigned.
- Strict Adherence to Standard Operating Procedures (SOPs), Quality Management Systems (QMS), and Current Good Manufacturing Practice (cGMP) guidelines.
Minimum Job Requirements...
- High School Diploma – or equivalent Diploma with...
- 1 year of experience in customer service and...
- 1 year of experience in a laboratory environment to understand chemical handling.
- Associate degree in Chemistry, Pharmacy, or related field – or equivalent diploma is preferred with...
- 1 Year of experience in DEA Compliance or related regulatory compliance field.
Work Environment...
This job is operated in a professional office environment using typical office equipment (scanners, printers, computers, phones).
This role occasionally uses simple shop tools including but not limited to hand drills, wrenches, and pliers.
This role occasionally works both inside and outside in weather conditions of 30 degrees Fahrenheit in the winter or up to 90 degrees Fahrenheit in the summer, taking appropriate precautions as needed in the performance inspections.
Exposure to weather conditions such as rain and wind in the performance of duties.
The noise level is moderate to loud.
Fluctuations in Temperatures, Humidity, and Pressure throughout the inside and outside of the facilities.
Exposure to dust and fumes.
Exposure to the use of chemicals with the classification of Hazardous, Toxic, Corrosive, Flammable, or Oxidizing.
Primarily dominated English-speaking workplace.
Attendance at the office is required
Physical Requirements...
This is an active role with occasional walking between buildings daily. This position is a partially sedentary role, and some filing is required.
Ability to sit and stand in front of a computer for extended periods, with intermittent twisting/bend to reach instruments or supplies surrounding equipment.
Routinely stand, stoop, climb ladders, and walk in operations of duties with occasionally kneeling, crouching, and/or crawling.
This position would require the ability to lift 50 Lbs. (if an object weighs more than 50 Lbs. ARL requires this to be a two-person job or use of carts).
Ability to use hand strength and finger dexterity to perform fine manipulations of tool equipment including turning, pressing, twisting, and typing.
Must be able to wear Personal Protective Equipment (PPE).
Must be fluent in written and spoken English to receive and communicate information for standard and complex operations and emergencies clearly and accurately.
Requires visual acuity to read and write words and numbers and to see in the normal visual range including ability to distinguish colors with or without correction.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus with or without correction.
Requires hearing communications accurately with or without correction.
Must be able to tolerate fluctuations in temperature. This position will be required at times to assist with repairs to temperature controls.
AAP/EEO Statement
ARL Bio Pharma, Inc. provides equal employment opportunities to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law. ARL Bio Pharma, Inc. expressly prohibits any form of workplace harassment based on race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law. Improper interference with the ability of ARL Bio Pharma, Inc. employees to perform their job duties may result in discipline up to and including discharge. Further, the company takes affirmative action to ensure that applicants and employees are treated without regard to any of these characteristics.
