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Form of work Description/Comment: The AR&D laboratory supports, development and validation of analytical test methods, evaluation and testing of raw materials, and testing of non-commercial materials to support product development. The department provides analytical services to manufacturing, process development, validation and new material qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburg's Quality departmental policies.
II. Basic Function:
Independently review and audit analytical data including notebooks, chromatographic data and other analytical data reports. Document and communicate results both to the analysts whose work is under review and to laboratory management when required. Maintain proper records in accordance with all SOP's and policies.
III. Specific Activities, and Responsibilities:
Perform audits of analytical data to include but not limited to laboratory notebooks, chromatographic raw data, analysis reports, and other analytical data as required, against test methods, specifications, and other reference documents.
Initiate/facilitate/review documented deviations/process discrepancy reports/investigations of any reported or observed nonconformance found relative to data quality.
Approve analytical documents as the reviewer against applicable specifications/procedures.
Perform data certification in the electronic GLIMS system if applicable.
Actively participate in corrective actions and continuous improvements.
Assist in complying with any other company and /or departmental objectives as directed by AR&D management.
Deliver on commitments to meet customer expectations.
All other duties as assigned
IV. Knowledge Requirements:
Education or Equivalent:
Minimum BS degree in Chemistry, Biology, Microbiology or related sciences.
Minimum of 4 years relevant pharmaceutical laboratory/analytical experience
Knowledge/Skills Requirements:
Prior quality assurance experience of the executed batch record review is a must.
Working knowledge of cGMPs regulations.
Certified Quality Auditor is a plus.
Must possess good interpersonal skills.
Ability to effectively communicate with co-workers.
Good organizational skills required.
Prior HPLC/GC Instrumental experience required.
Excellent oral and written communication skills.
Proficient in Microsoft Word, Excel, Access and Power Point. Good word processing skills.
Motivated, self-started, team player
Physical/Mental Requirements:
Ability to identify root causes of problems and develop solutions, which address causes rather than symptoms.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to work effectively under pressure to meet deadlines.
Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 101 2725 Scherer Drive North 13-4268760 St. Petersburg FL 33716 United States Education: Additional Job Details: - NOT REMOTE Shift - M-F 8 to 5 6 months with possible extension (possibility to go perm) Manager would like the following (preferred not required): Chromatography Experience with Empower is preferred; Experience with LabVantage LIMS is a plus; Experience with Trackwise quality system is a plus. Must be able to work independent as well as part of team. This position requires strong communication, organizational and interpersonal skills. Must also have excellent oral and written experience. MUST HAVES: 4 YEARS EXP WITH BS DEGREE. HPLC/GC INSTRUMENTAL EXPERIENCE. cGMP REGULATION EXPERIENCE.
II. Basic Function:
Independently review and audit analytical data including notebooks, chromatographic data and other analytical data reports. Document and communicate results both to the analysts whose work is under review and to laboratory management when required. Maintain proper records in accordance with all SOP's and policies.
III. Specific Activities, and Responsibilities:
Perform audits of analytical data to include but not limited to laboratory notebooks, chromatographic raw data, analysis reports, and other analytical data as required, against test methods, specifications, and other reference documents.
Initiate/facilitate/review documented deviations/process discrepancy reports/investigations of any reported or observed nonconformance found relative to data quality.
Approve analytical documents as the reviewer against applicable specifications/procedures.
Perform data certification in the electronic GLIMS system if applicable.
Actively participate in corrective actions and continuous improvements.
Assist in complying with any other company and /or departmental objectives as directed by AR&D management.
Deliver on commitments to meet customer expectations.
All other duties as assigned
IV. Knowledge Requirements:
Education or Equivalent:
Minimum BS degree in Chemistry, Biology, Microbiology or related sciences.
Minimum of 4 years relevant pharmaceutical laboratory/analytical experience
Knowledge/Skills Requirements:
Prior quality assurance experience of the executed batch record review is a must.
Working knowledge of cGMPs regulations.
Certified Quality Auditor is a plus.
Must possess good interpersonal skills.
Ability to effectively communicate with co-workers.
Good organizational skills required.
Prior HPLC/GC Instrumental experience required.
Excellent oral and written communication skills.
Proficient in Microsoft Word, Excel, Access and Power Point. Good word processing skills.
Motivated, self-started, team player
Physical/Mental Requirements:
Ability to identify root causes of problems and develop solutions, which address causes rather than symptoms.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to work effectively under pressure to meet deadlines.
Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 101 2725 Scherer Drive North 13-4268760 St. Petersburg FL 33716 United States Education: Additional Job Details: - NOT REMOTE Shift - M-F 8 to 5 6 months with possible extension (possibility to go perm) Manager would like the following (preferred not required): Chromatography Experience with Empower is preferred; Experience with LabVantage LIMS is a plus; Experience with Trackwise quality system is a plus. Must be able to work independent as well as part of team. This position requires strong communication, organizational and interpersonal skills. Must also have excellent oral and written experience. MUST HAVES: 4 YEARS EXP WITH BS DEGREE. HPLC/GC INSTRUMENTAL EXPERIENCE. cGMP REGULATION EXPERIENCE.
