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Adecco US, Inc. USA-Documentation Specialist II (Manufacturing/Quality) 1st Shift in Framingham, Massachusetts

Adecco Medical & Science is hiring a Documentation Specialist II for their pharmaceutical partner in Framingham, MA.

The anticipated wage for this position is between $43 and $44.20. Hourly wage may depend upon experience, education, geographic location, and other factors.

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria

Job Duties:

· Track and review change control documentation.

· Assist with the editing of quality documents (SOPs, guidelines, validation master plans, etc.) to ensure compliance with regulator requirements.

· Must be able to work quickly with a high degree of accuracy.

· Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.

· Prepare and/or maintain documentation pertaining to programming, systems operation, and user documentation.

· Translate business specifications into user documentation.

· Plan, write, and maintain systems and user support documentation efforts; including online help screens.

· Knowledgeable of commonly used concepts, practices, and procedures within a particular field.

· Rely on instructions and pre-established guidelines to perform the functions of the job.

Requirements:

· Minimum HS Diploma with a Minimum of 5 Years of experience or Bachelor's degree with 2+ years

Previous Pharma Experience

· Production record review experience would be ideal.

· Production SOPs, validation master plans, production records

· Ability to plan, write, and maintain systems and user support documentation efforts - this includes understanding where gaps are with new/ existing SOPs, steps to obtain required information for the process, and the ability to understand and analyze the documentation process

· Veeva (or similar system) & MS Office Suite (must have)

· Team player, familiar with guidance with multiple people, working with other stakeholders and or other departments

· Previous experience reviewing GMP production records/ Production record review (strong plus)

· Aseptic experience or understanding (upstream, downstream, etc.) (strong plus)

Pay Details: $43.00 to $44.20 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adeccousa.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

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