Position Summary:
Inspects, labels, and packages sterile drug product.
Performs all activities associated with inspecting, labeling, and packaging sterile drug product.
May transports materials, supplies, and finished products to designated locations as needed.
Collaborates with production, packaging/inspection, and distribution center personnel as needed to ensure workflow does not stop due to material availability, and proactively helps drive overall operational efficiency.
Essential Responsibilities/Duties:
- Initiates and fosters a spirit of cooperation within and between departments.
- Finished Drug Packaging:
o Visually inspect, label, package, and ensure proper storage of completed products according to cGMP.
o Utilize and understand proper gowning and garbing procedures as per applicable SOP.
o Read and follow all Pine Pharmaceuticals Standard Operating Procedures pertaining to job function.
Maintain understanding of all updates to all SOPs.
o Properly utilize all equipment and perform necessary maintenance activities as needed.
o Ensure product appearance meets all required specifications.
o Train as needed for new products.
- Communicates frequently and works inclusively with Team Leads, Supervisors, MQA, Training and other site personnel to meet the goals of the packaging & inspection department.
- Ensures compliance with all federal, state, regulatory bodies (FDA, DEA, BOP, DEC, OSHA) and local municipalities.
- Meets site goals and objectives as part of a team
Other Responsibilities/Duties:
- Cleans assigned areas as necessary.
- Maintain own workspace to be clean and free of clutter.
- Reviews own documentation for accuracy, makes corrections and/or escalates to supervision/MQA
- Provide support/input for the development and integration of new processes to improve safety, quality, efficiency, and cost
- May transport recycling and packaging waste to final on-site disposal location
- Maintains all personal cGMP related training in a current state
- Observes all environmental, health, and safety policies
- Performs other duties and tasks as assigned by management
Qualifications, Skills and Abilities Required:
- High school diploma or equivalent required.
- Good interpersonal skills and willingness to work with others
- Good oral and written communication skills
- Good organizational skills and attention to detail
- Ability to work effectively both as part of a team and individually
- Ability to give/receive constructive criticism
- Must be dependable/reliable/punctual, minimal unexcused absences if internal applicant
Experience Required:
- Prefer two years experience in a related field (manufacturing or pharmacy)
Physical Requirements:
- Must be able to stand on production floor for prolonged periods of time
- Must be able to walk floor for prolonged periods of time
- Must be able to sit at an inspection station for prolonged periods of time
- Must be able to pass visual acuity test
- Must be able to lift up to 35 pounds at times
- Must be able to climb small stepladders
- Must be able to wear appropriate PPE (goggles, gloves, scrubs, frock, hairnet, beard guard, mask) as needed based on work area and materials being handled in accordance with procedures and policies