Quality and Compliance Specialist (Analytical)

at  Piramal Healthcare Canada Limited

Riverview, Michigan, USA - 48193

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate14 Feb, 2022Not Specified14 Nov, 2021N/ASpreadsheets,Manufacturing Processes,Communication Skills,Chemistry,Method Development,Trackwise,Databases,Regulatory Requirements,Biochemistry,Analytical Techniques,Data Review,Epa,Osha,Validation,Word ProcessingNoNo
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Description:

POSITION SUMMARY: Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Quality and Compliance Specialist (QCS) to join our Analytical Services team. The QCS is responsible for review of the laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP and data integrity standards.

TO PERFORM THIS POSITION SUCCESSFULLY, AN INDIVIDUAL MUST BE ABLE TO PERFORM EACH ESSENTIAL DUTY SATISFACTORILY. THE REQUIREMENTS LISTED BELOW ARE REPRESENTATIVE OF THE KNOWLEDGE, SKILL AND/OR ABILITY REQUIRED:

  • Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
  • Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
  • Identify and protect the original technical information as part of the company property.
    Qualifications

EDUCATION/EXPERIENCE.

  • Bachelor’s degree in Chemistry, Biochemistry or related field.
  • Minimum two (2) to five (5) years of experience in using HPLC, GC, and/or related analytical techniques. QC data review experience a plus.
  • Technical Writing Experience Desirable.
  • Good knowledge of CGMP requirements, ICH, FDA guidelines.
  • Knowledge of analytical instrumentation and techniques.
  • Skills in interpreting and trending analytical data and instrumentation/equipment software.
  • Knowledge of Agilent OpenLab, SAP, Trackwise, LIMS a plus.
  • Understanding of method development, validation, transfer and stability requirements.
  • Strong software application skills including word processing, spreadsheets and databases.
  • Strong communication skills, both written and verbal.
  • Extensive knowledge of compliance in the pharmaceutical manufacturing processes (API).

Responsibilities:

KEY RESPONSIBILITIES.

  • Review any analytical data generated in the analytical lab (QC/AS) including but not limited to IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data according to cGMP, GDP, in a timely manner.
  • Ensure compliance with internal approved procedures, specifications and protocols of all generated data
  • Review all planned and unplanned deviations for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations
  • Interface with their supervisor, the analytical group(s) and QA on a daily basis.
  • Review of out-of-specification or out-of-trend investigations and/or deviations for accuracy, completeness and compliance to data integrity, written procedures, and cGMP regulations
  • Perform and or support lab investigations (e.g. OOS, deviations, CAPAs)
  • Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc.
  • Assist in the preparation of new or revised documentation as required, including but not limited to test methods, SOPs, protocols, reports and/or specifications.
  • Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, etc.)
  • Revise via change control documentation as required
  • Perform other related assignments and projects as required
  • Provide data and information pertaining to lab or systems for internal or external clients as requested
  • Where applicable, release of starting materials, raw materials, and cleaning verifications for GMP manufacturing
  • Perform other related assignments and projects as required

THE PHYSICAL DEMANDS AND WORK ENVIRONMENT DESCRIBED HERE ARE REPRESENTATIVE OF THOSE THAT MUST BE MET BY A TEAM MEMBER TO SUCCESSFULLY PERFORM THE ESSENTIAL FUNCTIONS OF THIS JOB. REASONABLE ACCOMMODATIONS MAY BE MADE TO ENABLE INDIVIDUALS WITH DISABILITIES TO PERFORM THE ESSENTIAL FUNCTIONS.

  • Physical Demands:
  • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
  • Long periods of standing and walking can be expected in this position.
  • This position may require long periods of sitting, typing, computer entry or looking at a computer.
  • Work Environment:
  • Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
  • Potential limited exposure to hazardous chemicals.
  • Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
    Primary Location: United States-Michigan-Riverview
    Work Locations: Riverview Ash Stevens LLC 18655 Krause Street Riverview 48193,,,,,,,,,,,
    Job: Analytical Chemistry
    Organization: Pharma Solutions
    Day Job
    Job Posting: 12-Nov-2021, 3:26:24 P


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Chemistry biochemistry or related field

Proficient

1

Riverview, MI, USA