QA Specialist I
ANI Pharmaceuticals, Inc.
3 days ago
On-site
Baudette, MN
Operations
Responsibilities:
- Assure quality of documentation and data; perform disposition of batch records for raw materials, packaging components, finished product release, and stability documents.
- Support Manufacturing and Packaging operations to ensure procedures are followed and meet cGMP requirements.
- Review notebooks, data sheets, electronic/ancillary data, logbooks, and reports for compliance with corporate SOPs and FDA guidelines; identify GMP deficiencies, initiate documentation for corrective actions, and monitor resolution.
- Assist in stability department with validation activities and/or annual report assembly.
- Perform disposition of finished product, raw materials, and packaging components; review finished product stability data.
- Conduct packaging line inspections/audits; verify packaging operations comply with applicable SOPs and cGMPs.
- Perform finished product attribute sample inspections and evaluate physical characteristics prior to packaging.
- Conduct annual retain sample inspections and manage finished product and raw material retain samples in the reserve sample room.
- Monitor GMP areas for compliance with general GMP requirements (e.g., proper gowning and cleanliness).
- Perform other duties as assigned.
Qualifications:
- Bachelor’s degree and 2 years’ experience in Quality Assurance or Quality Control.
- Knowledge of laboratory testing and raw data, particularly HPLC.
- Excellent computer skills; prior experience in a regulated environment.
- Problem solving skills; ability to coordinate multiple tasks in a fast-paced environment.
- Ability to read and follow procedures; work independently and in a team.
- Attention to detail; excellent interpersonal and organizational/follow-through skills.
- Excellent written and verbal communication skills.
- Knowledge of cGMPs.
- Must be able to travel occasionally.
Benefits/Compensation:
- Base salary range: $48,000–$52,000. Benefits include health/life/disability insurance, retirement savings plans, paid leave, paid holidays, and paid time off (many subsidized or fully paid).
- Assure quality of documentation and data; perform disposition of batch records for raw materials, packaging components, finished product release, and stability documents.
- Support Manufacturing and Packaging operations to ensure procedures are followed and meet cGMP requirements.
- Review notebooks, data sheets, electronic/ancillary data, logbooks, and reports for compliance with corporate SOPs and FDA guidelines; identify GMP deficiencies, initiate documentation for corrective actions, and monitor resolution.
- Assist in stability department with validation activities and/or annual report assembly.
- Perform disposition of finished product, raw materials, and packaging components; review finished product stability data.
- Conduct packaging line inspections/audits; verify packaging operations comply with applicable SOPs and cGMPs.
- Perform finished product attribute sample inspections and evaluate physical characteristics prior to packaging.
- Conduct annual retain sample inspections and manage finished product and raw material retain samples in the reserve sample room.
- Monitor GMP areas for compliance with general GMP requirements (e.g., proper gowning and cleanliness).
- Perform other duties as assigned.
Qualifications:
- Bachelor’s degree and 2 years’ experience in Quality Assurance or Quality Control.
- Knowledge of laboratory testing and raw data, particularly HPLC.
- Excellent computer skills; prior experience in a regulated environment.
- Problem solving skills; ability to coordinate multiple tasks in a fast-paced environment.
- Ability to read and follow procedures; work independently and in a team.
- Attention to detail; excellent interpersonal and organizational/follow-through skills.
- Excellent written and verbal communication skills.
- Knowledge of cGMPs.
- Must be able to travel occasionally.
Benefits/Compensation:
- Base salary range: $48,000–$52,000. Benefits include health/life/disability insurance, retirement savings plans, paid leave, paid holidays, and paid time off (many subsidized or fully paid).