Scientific Protein Laboratories is a biopharmaceutical leader in the development and cGMP compliant manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation.

Under general supervision, generates, reviews, revises, and issues current and new controlled documents. Assist in current operations in the document department. Provide traceability and accountability through control and release of documents as required by corporate and current Good Manufacturing Practices (cGMP).

Responsibilities

• Assure appropriate issuance and retrieval of controlled documents. Assure return or retrieve outdated or obsolete documents; assure all previously issued copies are accounted for and destroyed. Maintain relevant databases.
• Issue product batch/packaging records and properly assign lot numbers based on established procedures and production schedules.
• Assist in editing controlled documents for proper format and content per existing Standard Operating Procedures and cGMP guidelines.
• Assign and route controlled documents in accordance with document control SOPs. Assign effective dates and copies and places new or revised SOPs in proper locations throughout the facility.
• Maintain files on all controlled documentation. Files, scans and archives controlled documents KSAOs which will bring value to the team.
• Identifies patterns or connections between or among situations to identify key or underlying issues.
• Possesses the skill to obtain necessary facts and generate informed solutions.

High School Diploma or G.E.D., Associate's Degree or above in related discipline preferred and 2+ years experience.

SPL offers a competitive salary, a comprehensive benefits package and a pleasant work environment.

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

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