Quality Systems Specialist Mystic Pharmaceuticals

Reports to: QA Manager
The Quality System Specialist will assist the QA Manager in the following tasks:

- Provide support for creation of Quality Systems and Standard Operating Procedures
- Assist in the tracking modifications, proof-reading, editing, and formatting of documents as requested
- Develop work instructions, test methods, procedures, policies and any other documents necessary for accuracy and completeness and ensure compliance with cGMPs
- Participate in the development of the new processes, process transfers and continuous improvement, and issue resolution
- Support technical activities regarding verifications and validations: including protocol development, synchronization of interdepartmental activities, data evaluation, report writing
- Assist in the maintenance of historical files of all products and archival records; including but not limited to design history files, change control, validations, process validations, method qualifications, batch records, clinical studies, etc.
- Other duties as assigned

Requirements Include:

- Current knowledge of Documentation, Change Control and cGMPs in the pharmaceutical industry.
- Working knowledge of CFR 21 Parts 210, 211 and 820, and a sound knowledge of Quality Systems requirements
- At least 2 years experience in a manufacturing or processing quality environment, preferably in an FDA regulated industry required
- Able to meet short deadlines in a fast-paced, demanding pharmaceutical environment
- Must demonstrate excellent organizational skills, professionalism, and accuracy, in addition to the ability to follow-up to ensure project completion in a timely manner
- Candidate must have outstanding written, verbal, and computer skills with proficiency in MS Word, MS Access, MS Excel, MS Outlook, and Adobe Professional.

Location:	Cedar Park, TX United States