alphanumeric
Job Details
Technical Writer Marietta, PA Posted: 1/21/2025
Job ID#: 8126
Job Description: Technical Writer / Compliance Specialist
Location: Marietta, PADuration: 1 Year from Start Date (Potential for Extension and Conversion to GSK FTE)
Work Environment: 100% On-Site
Hourly Pay: $60-63
Alphanumeric is hiring a Technical Writer / Compliance Specialist to join our team, supporting a global leader in medical and pharmaceutical advancements. This role focuses on ensuring quality system compliance for the Technical Services (TS) department by managing quality documentation, leading investigations, coordinating corrective actions, and overseeing compliance with Environmental Health and Safety (EHS) and Good Manufacturing Practices (GMP).
Key Responsibilities
Quality System Compliance:- Manage quality system tasks, including SOP creation/revisions, training records, and change control coordination.
- Facilitate root cause analyses for deviations, lead cross-functional investigations, and implement corrective actions using methodologies like DMAIC.
- Represent TS in site-level change control meetings and manage related documentation.
- Ensure TS SOPs align with Global QMS, engineering standards, and EHS requirements.
- Track and trend quality data, including CAPAs (EHS and GMP), and prepare routine progress reports.
- Collaborate with manufacturing, supply chain, QA/QC, and regulatory teams to address discrepancies impacting product quality or safety.
- Act as a liaison with external regulatory authorities during audits.
- Develop internal GMP and EHS audit schedules and perform regular internal inspections.
- Monitor process health using scorecards and trending tools, escalating issues as needed.
- Ensure compliance with GMPs, NIH Guidelines, FDA standards, and industry regulations.
- Provide clear, accurate technical documentation to meet internal policies and regulatory requirements.
Job Requirements
EDUCATION:- B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry, Engineering or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
Qualifications and Skills
Education:- Bachelor's degree in a technical field, such as Microbiology, Biology, Biochemistry, Chemistry, Engineering, or Pharmacy. Equivalent experience with sufficient technical depth will also be considered.
- Minimum of 3 years' experience in pharmaceutical manufacturing or quality assurance, focusing on deviation investigations.
- Strong understanding of pharmaceutical facilities, equipment, and systems.
- Familiarity with GMPs, NIH guidelines, and FDA regulatory requirements.
- Proficiency in conducting root cause analyses and implementing corrective actions.
- Intermediate computer skills and the ability to manage technical documentation.
- Excellent verbal and written communication skills.
- Ability to work collaboratively in a matrix organization with cross-functional teams.
- Exceptional problem-solving and investigational abilities.
- Detail-oriented, highly organized, and capable of managing multiple priorities with minimal supervision.
- Demonstrates urgency, accountability, and integrity in all responsibilities.