Documentation Specialist jobs in Massachusetts

Description:

Works with Manufacturing to deliver timely batch record review across all shifts.

Reviews and approval of master batch records.

Develops appropriate disposition metrics, works with manufacturing personnel to achieve said targets. Generates and reports on metrics on agreed frequency

Creates training materials for subject matter input.

Track and manage periodic review of approved manufacturing procedures.

Develops strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.

Provides data to support management evaluation of performance trends.

Owns quality records (change control, CAPA’s, deviations) and delivers to timelines established.

Autonomously leads and manages projects to implement continuous improvement opportunities.

Lead and/or support root cause investigations related to performance trends and formal deviations.

Develops, implement and assess solutions for complex problems.

Anticipates risk and build contingencies to help mitigate impact.

Reviews document for accuracy and completeness.

Defends the validation programs and strategies to customer and regulatory auditors.

Performs weekly quality reviews of MasterControl database by assuring new documents have been entered using appropriate protocols.

Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP),

Additional Skills & Qualifications:

Associate degree with 6-8 years knowledge and experience of GMP documentation required.

Bachelor’s degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university.

Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.

Minimum one (6) year documentation experience and three (3) years related pharmaceutical or biotech industry experience. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.