Quality Compliance Manager
November 26, 2019
Click here to apply.
A Pharmaceutical company in Mahwah, NJ is currently seeking a candidate to fill a Quality Compliance position. The Quality Compliance Manager is responsible for performing activities within Quality Assurance as explained below. This position also contributes to the completion of routine technical tasks and any additional quality task identified.
This position is full time (Monday – Friday) 8:00AM – 5:00PM
Salary: Up to $90,000
- Support management by tracking department expenses against budget.
- Manage Distribution Center Quality Operations including, but not limited to:
- Review and maintaining existing Quality System ensuring compliance to Corporate and Agency Regulations.
- Support Quality Associates performing Incoming Inspection operations to ensure product is received and dispositioned following quality systems, including ensuring timely inspection, review and release products received at Mahwah Distribution Center(s)
- Ensuring compliance to the Product Returns Management.
- Ensure compliance towards investigations, reporting, and review and identify CAPA where applicable.
- Support distribution canter environmental monitoring to maintain cGMP required parameters and inspection ready conditions.
- Support the management of Controlled Substances, including the ordering, fulfillment of customer orders, processing and filing of all required DEA related documentation DEA related order processing, as required.
- Responsible towards cross departmental projects in providing quality/compliance oversight.
- Support regulatory inspections (DEA, FDA, NABP, State Board etc.,)
- Train employees and subordinates, where applicable (SOP Training etc.,)
- Tracking and trending of quality events related to the Distribution Center to ensure any and all incidents and subsequent CAPA activities are addressed.
- Support Quality ManaQement as requested.
- Work with GMP departments to ensure training is completed to support SOP deployment.
- Perform vendor & Internal Inspections to ensure compliance to cGMP, VAWD, DEA and local procedure.
- Identify areas within Mahwah Quality System and Distribution Center where operational excellence can be achieved and present to Quality and Management teams.
- Bachelor’s degree in Life Sciences or Technical/engineering field, or closely related scientific discipline.
- Minimum of 4+ years’ experience in a regulated pharmaceutical environment.
- Strong technical writing and communication skills required.
- Experience with of cGMPs, FDA, DEA regulations, and industry guidelines, as well as international regulatory guidelines desired.
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work as a contributing member of a team.
- Excellent verbal and written communication. Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook , Word, Excel, etc.
- Good communications skills, front runner.