Alpha Numeric
Technical Writer Job at Alpha Numeric in Marietta
Alpha Numeric, Marietta, PA, United States, 17547
Job Description: Technical Writer / Compliance Specialist
Location : Marietta, PA Duration : 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. Documentation and Standards :
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. Cross-Functional Coordination :
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. Audit and Process Monitoring :
Develop internal GMP and EHS audit schedules and perform regular internal inspections. Monitor process health using scorecards and trending tools, escalating issues as needed. Regulatory and Compliance Support :
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. Experience : Minimum of
3 years' experience in pharmaceutical manufacturing or quality assurance , focusing on deviation investigations. Technical Skills : 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. Soft Skills : 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.
* Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. * Demonstrated problem solving and investigational skills. Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. * 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 as necessitated by regulatory agencies and internal policy. * Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes. * 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 highly complex matrix environment. * Able to prioritize and decide appropriate course of actions and to effectively implement decisions. * Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions. * Able to maintain attention to detail while executing multiple tasks. * Able to perform job duties with minimal supervision. * Must be able to address complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems. * Must have an aptitude for facilitating a team environment and working independently toward the goal of completing product investigations. * Must operate cross-functionally and be able to lead in a matrix organization. * Sense of urgency, flexibility and accountability. Intermediate computer skills required. * Stay current on developments in the field and company Standards. * Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines. * Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Why Join Us?
By joining Alphanumeric, you'll contribute to meaningful work that improves lives while collaborating with a team of experts in a fast-paced, dynamic environment.
Location : Marietta, PA Duration : 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. Documentation and Standards :
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. Cross-Functional Coordination :
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. Audit and Process Monitoring :
Develop internal GMP and EHS audit schedules and perform regular internal inspections. Monitor process health using scorecards and trending tools, escalating issues as needed. Regulatory and Compliance Support :
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. Experience : Minimum of
3 years' experience in pharmaceutical manufacturing or quality assurance , focusing on deviation investigations. Technical Skills : 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. Soft Skills : 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.
* Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. * Demonstrated problem solving and investigational skills. Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. * 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 as necessitated by regulatory agencies and internal policy. * Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes. * 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 highly complex matrix environment. * Able to prioritize and decide appropriate course of actions and to effectively implement decisions. * Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions. * Able to maintain attention to detail while executing multiple tasks. * Able to perform job duties with minimal supervision. * Must be able to address complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems. * Must have an aptitude for facilitating a team environment and working independently toward the goal of completing product investigations. * Must operate cross-functionally and be able to lead in a matrix organization. * Sense of urgency, flexibility and accountability. Intermediate computer skills required. * Stay current on developments in the field and company Standards. * Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines. * Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Why Join Us?
By joining Alphanumeric, you'll contribute to meaningful work that improves lives while collaborating with a team of experts in a fast-paced, dynamic environment.