ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.
About The Role
This position is responsible for providing support to the Manufacturing and Packaging Operations to ensure relevant procedures are followed and meet GMP requirements. This includes, but is not limited to the following:
3rd Shift Sunday - Thursday 11:15 PM to 7:15 AM
Position Responsibilities:
Responsibilities include but are not limited to:
Perform packaging line inspections/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs.
Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging.
Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room.
Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements.
Perform other duties as assigned or requested.
About You
Bachelors degree is required. Chemistry, medical technology, microbiology preferred.
Must have experience in a GMP environment, academic or otherwise.
1-2 years experience working within Quality Assurance preferred
Experience following laboratory procedures and systems in Pharma or similarly regulated environment.
Computer skills
Previous work in a regulated environment
Problem solving skills
Ability to coordinate multiple tasks in a fast paced environment
Ability to read and follow procedures
Ability to work independently
Attention to detail
Excellent interpersonal skills
Excellent organizational and follow through skills
Excellent written and verbal communication skills
Knowledge of GMPs
Must be able to work within a team environment
Must be able to work possible shift changes
Must be able to travel occasionally
Benefits & Perks
Medical
Dental
Vision
Life Insurance
Short-Term Disability and Long-Term Disability
Employee Assistance Program
401(k) Savings Plan
Company Paid Holidays (10)
Paid Time-Off
Other Paid Leave
Employee Stock Purchase Plan (ESPP)
Opportunity to advance in company positions
THE PERSON HIRED FOR THIS POSITION MUST BE ABLE TO RELOCATE TO BAUDETTE, MINNESOTA AT TIME OF HIRE
Please note that ANI does not accept search agency or third-party emails, calls, or solicitations.
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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