Quality Assurance Specialist

About Us
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:

2nd Shift Monday -Friday 3:15 pm to 11:15 pm

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.  

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