Job description

summary / objective
This role supports activities within the Quality Assurance Stability Program Management group at Sovereign. Other tasks may be assigned based on needs of the department and Quality Assurance.

essential functions

• Assists in the maintenance of the Master Stability List.
• Develops, Reviews, and Approves the Master Stability Pull List.
• Generate stability graphs.
• Perform expiry dating / shelf-life confirmations.
• Performs stability study initiation and sample pulls from chambers.
• Revise and review Standard Operating Procedures (SOPs) and Forms associated with the Stability Program.
• Assist in stability sample destruction.
• Author and review stability reports.
• Author and review stability protocols, not limited to (Base Stability Protocols, Lot Specific Stability Protocols, and any Special Protocols (e.g., Shipping, Bulk Hold, etc.)
• Monitor and maintain Stability Chamber inventory.
• Enter data into the Scientek System.
• Aid in the support of Deviations and Investigations associated with Stability Program management.
• This role ensures and maintains the organizations compliance with Food and Drug Administration (FDA) 21 CFR Part 4, 11, 210, 211, and 820 compliances.
• Perform other tasks as assigned.

work environment

This role operates in a professional office environment. Business casual/casual attire is required. Occasionally, this role requires visits and access to both the manufacturing and laboratory environments where appropriate Personal Protective Equipment (PPE) is mandated. This role requires the use of standard office equipment such as computers, phones, photocopiers, and fax machines. Extended work hours may be required based on needs of the department and organization.

physical demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee will be required to sit at a computer for long periods of time and/or periodically be on their feet for long periods of time. This job requires the ability to lift a maximum of twenty (20) pounds.

position type/expected hours of work
This is a full-time position. Core work hours are Monday through Friday, 8 a.m. to 4:30 p.m. Extended work times (earlier or later) or weekend work may be required. Some flexibility in times may be coordinated with approval of the department manager.

management responsibilities

· None

required education and experience

· Associate Degree in scientific discipline.

· 3 years (minimum) experience in stability program management work or equivalent pharmaceutical analytical testing experience.

· Strong knowledge of pharmaceutical GMPs.

· Good written and oral communication skills.

· Computer literate with working knowledge of Microsoft Office applications.

preferred education and experience

· College degree in Chemistry or other technical disciple (i.e., Biology, Engineering, etc.)

· 3 years’ experience in stability program management work.

work authorization/security clearance (if applicable)

· Authorized to work in the United States

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Referral program
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Application Question(s):

• How many years of Stability experience do you have?

Education:

• Associate (Required)

Language:

• English (Required)

Work Location: One location

blackflymedia.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, blackflymedia.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, blackflymedia.com is the ideal place to find your next job.