Quality Control Specialist

Pay range: 32-42/hr
*depending on experience

Summary:
Under general direction, functions as the Specialist Quality Control working at the Corporate QC Center.

Description:
Job Details: Under general supervision, this position will perform routine procedures (i.e., NC/CAPA/CC) and process improvements projects to support Corporate Quality Control. Specific responsibilities include performing investigations to support corrective actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will also be responsible for documenting, computing, compiling, interpreting, reviewing and entering data. Additional responsibilities include providing and communicating results, maintaining global process trackers, develop project plan, support Business Continuity and Risk Management objectives, and initiating and/or implementing changes in controlled documents. Must learn and comply with safety guidelines, and cGMPs/CFRs which includes, but is not limited to, the maintenance of Corp QC training portfolio, training records, multisite procedures, CAPA/Change control records, written procedures and general support to Corporate QC improvements projects.

FUNCTIONS

1. Provide summary reports, data analysis and ensure flow of communication between RM Networks including following up and resolving issues that arise.
2. Provide expert support to RM IQA network.
3. Coordinates, manages, and performs changes to the multisite documents or in response to change requests approved by management.
4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project life cycle.
5. Ensure compliance – which includes implementing procedures that enhance GMP and safety.
6. Manage existing and/or develop and implement new programs, processes and methodologies
7. Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
8. Support of investigations and corrective actions.
9. May serve as subject matter expert to develop technical training.
10. May perform routine work in a specific area of responsibility as necessary.
11. Represents the department/organization on various team.
12. Independently responsible for following through on multi-site action items.
13. May interact with regulatory agencies regarding area(s) of responsibility including written responses.
14. May resolve issues with outside resources.
15. Performs special projects as requested by supervisor.
16. Available to work overtime or weekends to conduct any special assignment as per business request.

*Other functions that may be assigned EDUCATION/LICENSES

? Doctorate degree in Science or Chemistry
OR
? Master’s degree in Science or Chemistry & 3 years of directly related experience
OR
? Bachelor’s degree in Science or Chemistry & 5 years of directly related experience COMPETENCIES/SKILLS

1. Understand, support and demonstrate the values.
2. Excellent communication skills, facilitation and presentation skills.
3. Excellent technical writing skills.
4. Strong computer operation skills including Word processing, presentation, database and spreadsheet application skills.
5. Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
6. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
7. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
8. Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
9. Knowledge of pharmaceutical processes.
10. Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
11. Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
12. Extensive knowledge and application of GMPs/CFRs.
13. Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines.
14. Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
15. Extensive knowledge and application of SAP Quality Management (QM) Module
16. Advanced skills in solving complex problems.
17. Advanced data trending and evaluation.
18. Strong skill in working independently and to effectively interact with various level.
19. Ability to interact with regulatory agencies both orally and in writing.
20. Initiate, coordinate and lead cross functional team.
21. Excellent skill in leading, motivating, influencing, and negotiating.

PREFERRED QUALIFICATIONS

• Major in Science and / or Chemistry with approved Computer Sciences courses