Job Description

• Prepare new and revised documents such as forms, standard operating procedures, and batch records. 
• Ensure content accuracy and conformance to established standards. 
• Assist the department Manager in the overall direction, coordination, preparation and approval of controlled documentation, which will result in the affectivity and control of quality manufactured products, in accordance with production operating systems, procedures, compendia and quality control standards.

Technical Writer will perform the following activities:

Analyze existing procedures for concurrence with correct department methods and production records relative to company policies, governmental regulations and license requirements. Specifically documents related to test methods, batch records, material specifications, standard operating procedures, and manufacturing and laboratory forms.

Write procedures that reflect the most effective systems within company policies and government regulations to reduce misunderstanding and usability.

Write procedures with appropriate details that are easily understood and readily usable for consistency in training.

Respond to audit items specifically related to test methods, batch records, material specifications and standard operating procedures.

Work with Pharmaceutical Technology, Analytical Development, Manufacturing, Laboratories and Contract Customers to gather information as requested for inclusion in their procedure, method, specification, or batch record.

Reviews product change request information for correct presentation, completeness, and impact.

Determine if existing documentation/procedures are:

Current and consistent between similar documents.

Meet internal control policies and regulations.

Require changes based on investigations, audit responses, developmental, or compendia revisions.

Maintain Standard Operating procedures related to Laboratory test procedures, Material Specifications, and Batch record related documents.

·Assist the department Director in managing the physical preparation, approval and maintenance of all master batch documents and product history files for plant location, including all support documents to comply with procedures, policies and regulations

Assist the department Director review and approve master batch documents for production in accordance with regulatory, internal requirements and product modifications.

Assist manufacturing personnel and laboratory analysts develop and analyze procedures and/or forms to improve product/quality control needs to increase efficiency and improve yields and reduce costs.

Collaborate with production, Regulatory Affairs, Compliance, Quality Assurance and other personnel on technical problems and/or requirements and recommend policies, systems, tests and standards for product control.

Assist in the control and maintenance of the company's master database of stock titles and numbers for raw materials, intermediates, packaging materials to improve product control.

Assist Quality Control, Materials Management and laboratories in resolving quality problems and increasing reliability of quality of purchased material.

Handles assignments as necessary to meet PPI and contract customer commitments.

Collects and analyzes the information necessary to complete the creation and revision to test methods, material specifications, forms, batch records etc. including method and product validations.

Initiates the necessary change controls to maintain compliance and revise existing documentation.

Reviews the impact of the proposed changes with regards to other support documen

Provides requested documentation related to audits, laboratory support, and production.

Participates in FDA, CBER, and Contract Customer audits in regards to test methods, material specification, forms, and batch records.

Maintain databases related to control documents.

Issue memos to documents impacted by a product change request to assure compliance to the change request until all impacted documents are updated. Follows up to assure that applicable change controls to impacted documents are initiated.

Review requested form revision and impact of the change against SOP, batch record, test method, etc.

DELIVERABLES:

 Analyze existing procedures for documents related to test methods, batch records, material specifications, standard operating procedures, and manufacturing and laboratory forms.

Write procedures with appropriate details that are easily understood and readily usable for consistency in training, within company policies and government regulations to reduce misunderstanding and usability.

Responds and provides requested documentation to audit items specifically related to test methods, batch records, material specifications and standard operating procedures.

Work with multiple departments and contract customers to gather information as requested for inclusion in their procedure, method, specification, or batch record.

Maintain Standard Operating procedures related to laboratory test procedures, material specifications, and batch record related documents.

Assist the department/management in the review and approval of master batch documents for production in accordance with regulatory, internal requirements and product modifications.

Review and approve GMP training guides in accordance with regulatory and company policies.

Assist in the control and maintenance of the company's master database of stock titles and numbers for raw materials, intermediates, packaging materials to improve product control; maintain databases related to control documents.

Reviews standard operating procedures, license requirements, USP and other government regulations related to revisions and new documentation.

Initiates the necessary change controls to maintain compliance and revise existing documentation.

Participates in FDA, CBER, and Contract Customer audits in regards to test methods, material specification, forms, and batch records.Review requested form revision and impact of the change against SOP, batch record, test method, etc.

Qualifications

QUALIFICATIONS:

• Bachelors’ Degree preferred
• 3-5 years of experience in pharmaceutical industry (Pharma, Bio, Med Device) and has a solid grasp of manufacturing process equipment and cGMP.
• Proficient with Microsoft Office Applications – Word, Excel, Access, PowerPoint, Outlook, Visio, etc.
• Good written communications skills

Additional Information

1. All your information will be kept confidential according to EEO guidelines.
2. Please attach WORD resume in your profile
3. Work is on-site
4. THIS IS A CONTRACT ASSIGNMENT NOT A FULL-TIME JOB
5. 1099 OR W2
6. MUST BE LOCAL to St. Louis MO - there is no relocation assist for this consultaing assignment
7. 6+ month assignment