Biopharma Supervisor, Technical Writer and QC Review

  • Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Basic Function and Scope of Responsibility: The BioPharma Technical Writer and Quality Control Reviewer Supervisor is primarily responsible for needed technical writing of the BioPharma Research and Development Team. Additionally, the supervisor will direct the activities of technical writers and Quality Control Reviewers and ensure that the overall team performance meets required objectives.

Qualifications

Essential Job Duties:

• Leads Technical Writing and Quality Control Reviewing teams including scheduling oversight.

• Provides leadership and supervision for Technical Writers and Quality Control Reviewers and for projects that these associates are contributing to ensure program productivity and efficiency.

• Work closely and effectively with R&D, Laboratory Operations, Technical Operations, and Project Management teams to ensure that technical writing and Quality Control Reviewing tasks are progressing and milestones are achieved pursuant to organization and/or client timelines.

• Commitment to high quality of work and productivity.

• When appropriate, identify and develop training programs for Technical Writers and Quality Control Reviewers.

• Promote a culture of continuous learning by mentoring and training others and by participating in continuing education and training programs.

• Plan, develop, organize, write and edit forms, protocols, reports, procedures and technical aspects of internal and external written communications and publications.

• Implement / enhance sound practices in technical writing.

• Analyze documents to maintain continuity of style of content.

• Manage updates and revisions to technical documents.

• Manage and direct activities of direct report through effective hiring, onboarding, training, and supervision of work activities.
• Conduct regularly scheduled one-on-one meetings with direct report focused on performance goals, progress, and career growth and development.

• Assess team member by conducting effective performance reviews, and coaching through necessary performance improvements as needed.

• Conduct regular team meetings and/or provide regular communication to team members.

• Serve as an escalation point within the BioPharma R&D and Technical Operations teams for regulatory questions.

• Assist in key activities supporting quality within the BioPharma R&D and Technical Operations teams:

o Aid implementing quality systems related to pre-validation and validation (e.g., Electronic Lab Notebook, proper utilization of NCE reporting software, approaches to quality control, etc.).

o As needed, aid in identifying and tracking patterns in pre-validation / validation deviations

• Other duties as assigned by BioPharma Services R&D management

 

Essential Knowledge, Skills and Abilities:

• BS or BA in biological, physical, chemical, or clinical laboratory science. 4 years’ experience in a biological laboratory setting preferred

• Goal oriented, with excellent time management and organizational skills

• Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization

• Excellent verbal & written communication skills

• Ability to effectively solve problems and make sound independent decisions

• Analytical judgment, problem solving skills, accuracy and detail oriented

• Ability to work efficiently and independently with little or no supervision

• Ability to keep sensitive information confidential

• Ability to coach, train and mentor others

• Ability to build teams, motivate and influence associates at various levels

• High level of proficiency with PC based software programs

 

Physical Requirements:

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead

• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting

• Ability to continuously operate a personal computer for extended periods of time (4 or more hours)

• Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions

• Ability to stand for extended periods of time as necessary in the laboratory (4 or more hours)

• Ability to lift and move items weighing up to 15 pounds The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional Information

  • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays

Applicants must be authorized to work for ANY US employer. We are unable to sponsor or take over sponsorship of an employment Visa at this time

Eurofins Viracor BioPharma Services are committed to promoting an equal employment opportunity workplace environment and is an equal opportunity employer. It is the policy of the Company that all qualified applicants will receive consideration for employment  without regard to race, color, religion, sex, age, national origin, citizenship, pregnancy, genetic information (GINA), disability, military and/or veteran status, and/or any other status protected by applicable Federal, state, or local law.  The Company’s policy is to recruit, hire, train, promote and administer all employment-related matters on the basis of an individual's qualifications, abilities and efforts without regard to protected status.

 

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Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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