Description

• Prepare, maintain, control and route product files and master production batch records.
• Create, prepare, maintain, control, and route all Standard Operating Procedures, (SOPs) Work Instructions (WIs) and Forms.
• Maintain knowledge of FDA and NASC regulations that apply to the facility. Facilitate the site's annual Good Manufacturing Practices (cGMPs) and Food Safety training and all new hires.
• Assist in performing internal auditing and FDA PCQI (Preventive Control Quality Individual) support roles and responsibilities.
• Create, prepare update/revise Master Manufacturing Control Records (MCR) and Packaging Control Records (PCR) for the Production department according to the request of Production, Quality Management, and the Specification Change Management System. Ensure correct MCRs and PCRs are available for use for the manufacture and packaging of Central Life Sciences' products. These records must meet cGMP requirements.
• Create, prepare, update/revise, train and assist departments in the preparation of CB facility SOPs/SPRs, WIs and Forms. Coordinates approvals and ensures all departments SOPs, WIs and Forms are updated and available for the facility. Assists with and administers departmental procedure training of facility employees and newly hired employees.
• Coordinate an annual review of all the SOPs, WIs and Forms to assure they are reviewed by the appropriate personnel and revised when process improvement is met.
• Facilitate the annual cGMP training for all Council Bluffs employees and all new hires.
• Responsible for managing and maintaining CB training database along with procedure matrix.
• Assist in issuing non-conformance reports and request corrective actions from vendors.
• Assist in investigating customer complaints on animal food supplements, animal drug products and pet care products.
• Assist in maintaining data for Annual Product Review and scan and review production records.

• This position requires significant inter-departmental interaction.
• Should be knowledgeable of Quality Systems, NASC, Food Safety and GMP guidelines.
• Should be familiar with auditing standards.
• Must be highly proficient in Microsoft WORD and ADOBE Professional.
• Must possess excellent organizational and interpersonal skills, as well as oral and written communication skills.

• High school diploma with a minimum of 3-5 years documentation organization/handling experience and appropriate seminar experience.
• Proficient with all internal office systems and applications, documentation storage and retrieval systems, archival of documents, etc.
• Preferably a bachelor's degree.

• Normal laboratory and manufacturing conditions require safety gear and temperature conditions which may vary from cool to very warm. There can be exposure to potentially toxic substances.

• Comprehensive Medical, Dental, and Vision Insurance
• Free Life and Disability Insurance
• Health and Dependent Care Flexible Spending Accounts
• 401k with 3% company match and annual employer discretionary contribution
• Paid vacation, holidays and sick time
• Employee Assistance Program
• Access to thousands of free online courses
• Discounts on cell phones, movie tickets, gym memberships, and more!
• Education Assistance (both college degrees and professional certifications)
• Referral Program with cash bonus
• Access to on-demand pay
• Paid parental leave