compliance specialist - level 2.

　　marietta , pennsylvania

　　posted january 17, 2024

　　job details

　　summary

　　$38 - $40.35 per hour

　　contract

　　bachelor degree

　　category life, physical, and social science occupations

　　reference47248

　　job details

　　job summary:

　　As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future. To be recognized as a crucial part to furthering this goal, join this growing team now!

　　location: Marietta, Pennsylvania

　　job type: Contract

　　salary: $38.00 - 40.35 per hour

　　work hours: 9 to 5

　　education: Bachelors

　　responsibilities:

　　This position will perform deviation (unplanned events) investigations, identify root cause through root cause analysis (RCA) and determine CAPAs.

　　Investigate manufacture deviations (unplanned events)

　　Perform root cause analysis, using RCA tools.

　　Determine robust corrective actions and / or commitments.

　　Write deviations in SAP and prepare clear, concise reports from outcome of investigations.

　　Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.

　　For RCA, review records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents.

　　Communicate immediately with QA and Operations management for all manufacturing discrepancies that impact product quality or safety.

　　Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, company standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.

　　qualifications:

　　EDUCATION:

　　B.S or B.A in a technical discipline (Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy, Engineering).

　　Degree in other discipline if sufficient technical depth has been achieved from professional experience for the job purpose.

　　Minimum Level of Job-Related Experience:

　　Minimum of 2 years of demonstrated professional experience investigating manufacturing deviations, either in a QA, compliance or manufacturing role in the pharmaceutical industry or equivalent, preferably in aseptic processes/areas.

　　In-depth knowledge of root cause analysis methodologies, through training and practice.

　　Proficient on ing RCA for deviations investigations.

　　Proficient on deviation writing

　　Other Job-Related Skills/ Background:

　　Demonstrated problem solving and investigational skills.

　　The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.

　　The ability to clearly write technical documentation.

　　SAP skills are a plus

　　Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines

　　Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to knowledge to daily activities.

　　Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to to quality operations and compliance.

　　Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA. Ability to work in a high complex matrix environment.

　　Able to maintain attention to detail while executing multiple tasks.

　　Able to perform job duties with minimal supervision.

　　Sense of urgency, flexibility and accountability.

　　Intermediate computer skills required.

　　skills: Quality control, Quality Assurance, CAPA, Biology, Chemistry, Microbiology, GMP (Good Manufacturing Practice)

　　Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

　　At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

　　Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

　　Applications accepted on ongoing basis until filled.