QC Chemist
ANI Pharmaceuticals, Inc.
4 days ago
On-site
Baudette, MN
Operations
Position Summary:
- Independently perform laboratory procedures per Standard Operating Procedures (SOPs), apply analytical expertise to prepare reports/procedures, and mentor entry-level analysts.
Position Accountabilities:
- 50% Perform laboratory testing on material/product samples; prepare standards/samples; set up and confirm equipment/instrument operation; collect data and generate/report results per test methods and SOPs; report discrepancies; assist/mentor peers.
- 25% Review data per approved test methods, investigational plans, and protocols per SOPs; assess data integrity; document findings; help correct deficiencies.
- 10% Calibrate, perform preventive maintenance, and repair assigned equipment as needed; update equipment procedures.
- 10% Perform cGMP tasks (monitor expiry dates, audit documentation/logbooks, order supplies); prepare PPA’s, investigation reports, and Method/SOP/IOP revisions.
- 5% Other duties as assigned.
Qualifications:
- Required: Bachelor’s degree in Chemistry or closely related field.
- Required: 2–5 years analytical chemistry lab experience in a pharmaceutical or similarly regulated environment.
- Core: Ability to work independently; demonstrated Laboratory cGMP expertise; follow written procedures; perform technical writing; organization/communication/interpersonal skills.
- Training: Policy/SOPs, lab orientation & safety, specialized equipment/test methodology, Analyst Certification.
Preferred:
- Post-graduate education in Chemistry/Pharmacy/related field.
- 1 year ANI Pharmaceuticals analytical lab and/or testing methodology; 3–5 years regulated analytical lab experience; experience developing lab procedures/systems.
Physical/Other:
- Handle fine glassware/sampling devices; data entry; lift up to 20 lbs; occasional travel.
Benefits:
- Health insurance; life/disability insurance; retirement savings; paid leave/holidays/PTO (subsidized or fully paid by company).
Compensation:
- Base salary range: $48,000–$52,000.
- Independently perform laboratory procedures per Standard Operating Procedures (SOPs), apply analytical expertise to prepare reports/procedures, and mentor entry-level analysts.
Position Accountabilities:
- 50% Perform laboratory testing on material/product samples; prepare standards/samples; set up and confirm equipment/instrument operation; collect data and generate/report results per test methods and SOPs; report discrepancies; assist/mentor peers.
- 25% Review data per approved test methods, investigational plans, and protocols per SOPs; assess data integrity; document findings; help correct deficiencies.
- 10% Calibrate, perform preventive maintenance, and repair assigned equipment as needed; update equipment procedures.
- 10% Perform cGMP tasks (monitor expiry dates, audit documentation/logbooks, order supplies); prepare PPA’s, investigation reports, and Method/SOP/IOP revisions.
- 5% Other duties as assigned.
Qualifications:
- Required: Bachelor’s degree in Chemistry or closely related field.
- Required: 2–5 years analytical chemistry lab experience in a pharmaceutical or similarly regulated environment.
- Core: Ability to work independently; demonstrated Laboratory cGMP expertise; follow written procedures; perform technical writing; organization/communication/interpersonal skills.
- Training: Policy/SOPs, lab orientation & safety, specialized equipment/test methodology, Analyst Certification.
Preferred:
- Post-graduate education in Chemistry/Pharmacy/related field.
- 1 year ANI Pharmaceuticals analytical lab and/or testing methodology; 3–5 years regulated analytical lab experience; experience developing lab procedures/systems.
Physical/Other:
- Handle fine glassware/sampling devices; data entry; lift up to 20 lbs; occasional travel.
Benefits:
- Health insurance; life/disability insurance; retirement savings; paid leave/holidays/PTO (subsidized or fully paid by company).
Compensation:
- Base salary range: $48,000–$52,000.