Analytical Data Reviewer / Technical Writer

CordenPharma Colorado
Boulder, Colorado (US)
Job #0920
Full-time

CordenPharma Colorado
Job #0920

Boulder, Colorado (US)
Full-time

CordenPharma Colorado

CordenPharma Colorado is a highly sophisticated and entrepreneurial mid-sized pharmaceutical manufacturing company located in Boulder, Colorado. Our chemists and engineers are widely recognized for their history of innovation, having developed efficient manufacturing processes for some of the world’s most complex pharmaceutical compounds. CordenPharma Colorado also is acclaimed for its flexible manufacturing facilities and experienced workforce that can handle a wide range of production techniques and volumes. Ultimately, in partnership with our customers, CordenPharma Colorado is focused on its health care mission, proudly producing medicines that help patients around the globe survive and enjoy more comfortable lives.

OUR MISSION

Support our customers, leading pharmaceutical and biotechnology companies, in full and on time (DIFOT) with products and services. Our ultimate stakeholders and beneficiaries are naturally the patients in critical need of the sophisticated medications we manufacture.

We should never forget that the work we all do as an organization is critical to patients and ultimately improves peoples’ lives. There lies our right for existence, challenge, opportunity and motivation that should drive each of us individually at your respective sites and us together company-wide across the entire network.

SUMMARY

Ensures the quality and accuracy of analytical test data and documents by performing the following duties:

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • >> Performs full review of analytical testing data to include: raw materials, in-process samples, API-release lots, validation/transfer data and stability results generated by Research & Development (R&D) or Standards and Stability (S&S) Analytical Chemists.
  • >> Verifies calculations, document versions, supporting logbook data, raw data (e.g. chromatography data, integrations, calibrations, system suitability) and transcription of data into final reports.
  • >> Ensures compliance with GxPs, SOPs and Client requirements within clinical, registration and validation programs with clinical phase appropriate (pre-clinical to phase III) review.
  • >> Performs comparison of results to specifications and batch records.
  • >> Participates in review of standards, reagent preparation and instrument logs.
  • >> Assists in the development and review of clinical method SOPs and specifications.
  • >> Assists in the drafting and review of controlled SOPs, methods, and specifications within the Quality organization.
  • >> Assists in the drafting and review of transfer, verification and validation protocols and reports.
  • >> Assists in the drafting and review of project reports pertaining to analytical method development and qualification.
  • >> Authors and coordinates change control documentation in support of analytical activities required for manufacturing process start up.
  • >> Works closely with laboratory staff to monitor lab performance, helps investigate root causes of errors and identifies areas for improvement.
  • >> Copying, filing and scanning documents as required for internal and client use.

LEADERSHIP & BUDGET RESPONSIBILITIES

Demonstrates positive attitude. Supports a positive, healthy and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all of their knowledge, training, ability and experience.

QUALIFICATIONS

To perform this job 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor’s degree in chemistry or related sciences with minimum of 2 years of relevant experience.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and analytical documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to management.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply statistical concepts such as significant figures and analysis of variance.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

Domestic and international travel may occasionally be required.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to work with hands; and talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may frequently enter laboratories to retrieve/copy data where toxic and/or caustic chemicals are used; thus there is a risk of exposure. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

  • >> Presentation and persuasion skills.
  • >> Attention to detail and ability to organize work.
  • >> Developed written and verbal communication skills.

SALARY

This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.

Application

To apply, please click on the “Apply Here” button. An email box will open to forward a copy of your resume to our Human Resources department for review. Please include the job number and title in the subject line:

Job #0920 – Analytical Data Reviewer / Technical Writer

APPLY HERE